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BD Diagnostics Preanalytical Systems Product Catalogue 2006/7

2006 EMA Vacutainer Cat

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Page 1: 2006 EMA Vacutainer Cat

BD Diagnostics Preanalytical Systems

Product Catalogue 2006/7

Page 2: 2006 EMA Vacutainer Cat
Page 3: 2006 EMA Vacutainer Cat

Contents

BD in EMA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4The BD Vacutainer® System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5BD Vacutainer® Tube Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6BD Vacutainer® Label Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Training and Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Preanalytical Variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Finding Real Solutions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10BD Vacutainer® Paediatric Product Range . . . . . . . . . . . . . . . . . . . . . . . . 11

BD Vacutainer® Blood Collection SystemSerum Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Coagulation Tubes (Sodium Citrate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13ESR Tubes (Buffered Sodium Citrate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14ESR Products. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Serum Separator Tubes (BD SST™ II Advance) . . . . . . . . . . . . . . . . . . . . . 16EDTA Tubes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Cross Match Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Plasma Tubes (Heparin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Plasma Separation Tubes (BD PST™ II) . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Fluoride/Oxalate Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21Trace Element Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22Cell Preparation Tubes (BD CPT™) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Plasma Preparation Tubes (BD PPT™) . . . . . . . . . . . . . . . . . . . . . . . . . . . 24Blood Banking Tubes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25BD Eclipse™ Safety Needles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26Needles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Blood Collection Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Holders and Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

MicrocollectionBD Microtainer® Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Capillary Sampling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Other CollectionsCritical Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Urine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Accessory ProductsAccessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Product Quality Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35Additional Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36General Conditions of Sale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37BD Vacutainer® Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Authorised Distributors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

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BD in Eastern Europe, Middle East & Africa (EMA)

BD was established in New Jersey, USA over 100 years ago as a medical device manufacturer. Since then, BDhas advanced to be one of the largest companies of its kind in the world, with annual revenues exceeding $4billion. A strong base in proprietary technology makes BD a leading provider of medical products formedication delivery, blood collection, diagnostic testing, flow cytometry, infusion therapy, surgery, anaesthesiadelivery, ophthalmology, critical care, immunization, sharps disposal and medication management.

In EMA, BD has a strong presence throughout the region with representation offices, sales support, technicalservice and application training for all of its product range. In addition, BD EMA has a network of professionaldistributors who are highly regarded in the market place and who provide added value to our products andservices.

BD Diagnostics - Preanalytical SystemsBD Preanalytical Systems offer a complete system of tubes, needles, needle holders,and safety devices, which are optimally designed and tested for controlling preanalyticalvariability throughout the specimen collection and handling process. The BD Vacutainer®

range also includes a full range of products for paediatric and capillary blood collection.

BD Consumer HealthcareBD Consumer Healthcare produces a range of products and services designed to helppeople with diabetes live healthy lives. The BD Micro-FineTM range of insulin syringes, penneedles and lancets features some of the world’s thinnest and shortest cannulae, helpingto reduce the discomfort associated with insulin injections and blood capillary sampling.

BD Medical SystemsBD Medical Systems holds leadership positions in hypodermic needles and syringes,infusion therapy devices, insulin injection systems and prefilled drug delivery systems forpharmaceutical companies. It offers the industry’s broadest, deepest line of safetyengineered sharps products, as well as surgical and regional anaesthesia, critical care andsharps disposal products.

BD Ophthalmic SystemsBD Ophthalmic products comprise of two well-known names in ophthalmology, BD BeaverTM and BD VisitecTM. The product range includes an extensive range of sterile,single use devices and custom kits specifically designed for the ophthalmic surgeon.

BD BiosciencesBD Biosciences offers products suitable for clinical research and industrial applications. Theproduct range includes advanced clinical diagnostics systems for laboratories utilising flowcytometry, micro volume fluorimetry and molecular techniques as well as Innovative,leading edge instruments, reagents, culture systems and disposables for life science anddrug discovery research.

BD Diagnostics - Diagnostic SystemsBD Clinical Diagnostics offers new solutions with state-of-the-art instruments forinfectious disease diagnosis, such as a line of automated blood culture instruments andbacterial identification and susceptibility testing. BD Industrial Diagnostics offersdehydrated and prepared culture media, microbial identification systems, drug discovery,biopharmaceutical production, environmental monitoring and QA/QC applications.

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The BD Vacutainer® System

The BD Vacutainer® blood collection system is a closed evacuated system, which consists of a double-endedneedle with safety valve, BD Vacutainer® holder and sterile BD Vacutainer® tubes with pre-measuredvacuum.

Blood is collected by screwing the sleeve-covered end of the needle into the holder, then puncturing thepatient’s vein with the other end. After performing venepuncture the tube is then pushed into the holder,and the pre-measured vacuum of the tube allows the required volume of blood to be drawn.

There are many advantages to using the BD Vacutainer® blood collection system:

• It is hygienic because the blood is drawn directly into the tube eliminating user exposure.

• There is a wide range of colour-coded tubes available with pre-measured additives for a variety of analytical tests covering haematology, clinical chemistry, immunology chemistry and coagulation.

• There is no manual influence on the drawing of blood so the process remains consistent. The system is amore reliable alternative to the traditional needle and syringe technique1.

The tubes are colour-coded according to the appropriate additive and international standards (ISO 6710). Ifa tube is for reduced volume of draw, the closure is a translucent version of the colour-coded closure.

BD Vacutainer® Plus (plastic) blood collection tubes are made of clear latex free PET (PolyethyleneTerepthalate), which is shatter resistant and offers a clinically tested safer alternative to glass2.

BD Diagnostics - Preanalytical Systems also provide a range of other products including:

• Needles; in a variety of gauges and lengths, and including the BD EclipseTM safety needle.

• Various holders, adaptors and accessories, such as tourniquets.

• Products for the collection and analysis of urine.

• The BD Microtainer® paediatric collection, including BD Microtainer® tubes with BD MicrogardTM closure.

• Products for the collection of capillary blood samples from infants and adults, including BD GenieTM lancetsand BD QuikheelTM incision devices.

• Critical Care Collection including safety products for arterial blood gas collection and analysis.

BD Diagnostics - Preanalytical Systems offer the widest range of safety-engineered products in the evacuatedblood market.

1 VS5391 – Evaluation of Sample Quality and Analytic Results Between Specimens Collected in Vacutainer® Tubes and Current Syringe Collections. 11/982 Plastic blood tubes improve safety. Wayman DJ. Plastics News, June 6, 1994:52

Multiple sampleBD Eclipse™

safety needle withpink safety shield

Safety valve formultiple sampling

Pre-measuredvacuum

BD Hemogard™safety closure

BD single-use holder

Sterile evacuatedBD Vacutainer®

tube

5

Block label

Page 6: 2006 EMA Vacutainer Cat

BD Vacutainer® Training and Support

BD Vacutainer® Systems also offer their users a variety of high qualitytraining programmes to continually update healthcare workers in theuse of the BD Vacutainer® blood collection system. The BD Vacutainer®

blood collection system is designed to be simple in use, however, it isimportant for all staff to derive maximum benefit from the system,which is why we are committed to training staff in the hospital andcommunity.An introduction to the use of the BD Vacutainer® blood collection system is provided when a hospitalconverts to using BD Vacutainer® Systems products and services. This usually takes place prior to and duringthe introduction of the system, and includes all healthcare personnel concerned.

A variety of material is available to support the training programme, all of which is available from BDCustomer Services. This includes:

• BD OptimaSM – a comprehensive programme for improvinglaboratory efficiency.

• BD ValidoSM – a scientific process to specimen validation.

• Phlebotomy Education CD Rom Programme – this tool isdesigned for customer education in the use of the BDVacutainer® Systems and Safety Products. (Only available to BD Vacutainer® users.)

• BD Vacutainer® Quick Reference Guide: a step-by-stepguide to using the BD Vacutainer® blood collection system.

• A Guide to the Withdrawal of Blood: a comprehensiveguide to using the BD Vacutainer® blood collection systemin a pocket size booklet, which is available to all staff.

• Tube Guides: detailing the order of draw to be used whencollecting blood with more than one tube and which testseach tube should be used for. These are hospital specific andshould be arranged through the hospital’s Pathology Laboratory.

• Mixing Guidelines: giving guidance on this importantpreanalytical step.

• Clinical Study Papers: to support individual products can alsobe obtained.

• www.bd.com: BD’s website is a database of information andsupport for BD Vacutainer® users. For example: instructionsfor use, wall charts, product information and other educationalmaterials can be found here.

There is additional support in the form of:

• Customer Service Team – a team of 20 customer service representatives dedicated to helping and supporting our customers with product enquiries and order fulfilment information.

• Technical Specialists – technical specialists are available to answer scientific queries regarding BD™ products and services.

• Fully trained Sales Specialists – a team of 9 sales specialists, with an understanding of the laboratory environment, offering a wide range of support and advice through the introduction and use of BD Vacutainer® Systems products and services. They also offer advice on issues such as healthcare worker and patient safety, product optimisation and patient comfort.

BD Diagnostics - Preanalytical Systems, Customer Service Department, 21 Between Towns Road, Cowley, Oxford OX4 3LY Tel: 01865 748844/781699

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Page 7: 2006 EMA Vacutainer Cat

Preanalytical Variables

46-68% of all laboratory errors occur in the preanalytical phase5, and12.5% of preanalytical laboratory errors may cause an erroneousmedical decision6.In order for results to be as accurate as possible and to reduce thenumber of samples that need to be re-drawn, it is important to beaware of preanalytical variables in the laboratory.

• Order of draw – for multiple samples. 1. Blood Culture Bottles 2. Non-Additive Tubes 3. Coagulation Tubes 4. Additive Tubes.Coagulation tubes should be taken before plastic serum tubes as the clotactivator in plastic serum tubes may affect coagulation test results.

• Tourniquet time – must be removed after no more than one minute. If applied for longer the pressure from the tourniquet may cause elevated potassium levels. The tourniquet should be positioned 7.5cm to 10cm above the puncture site.

• Mixing – most tubes contain an additive or clot activator that needs to be mixed with the blood sample. Tubes with anticoagulants, such as EDTA, need to be mixed to ensure the specimen does not clot. If tubes are not mixed sufficiently, tubes with anticoagulant may clot and serum tubes may not clot completely resulting in the specimen needing to be re-drawn.

• Underfilling tubes – tubes should fill ± 10% of the label draw volume i.e. 4.5 ml tube should fill between 4ml – 5ml and tubes should have 25% head space (± 10%) to allow proper mixing (additive: blood).

• Light sensitive analytes – these include Bilirubin, Erthrocyte Protoporphyrin and Carotene. They must be transported in appropriate materials, such as foil, or should be collected in a light sensitive tube otherwise results may be affected.

• Storage of tubes – store all tubes at 4-25ºC (39-77ºF), unless otherwise noted on the package label. Extreme temperatures can reducethe effectiveness of the tubes and cause abstract results. Always remember to rotate your stock.

• Venepuncture site – veins that have thickened walls are harder to puncture than normal. In such circumstances, or if the chosen vein has been damaged by frequent venepunctures, it is best to look for another vein at a different site.

• Centrifugation speed – never centrifuge glass tubes at more than 2200g in a horizontal head (swinging bucket) centrifuge or above 1300gin fixed angle centrifuge heads, as breakage may occur. The clotting of a sample must be fully completed before centrifugation of serum tubes.

5. Source Becan-Mcbride K. Laboratory Sampling: Does the Process Affect the Outcome? Journal of Intravenous Nursing May – June 1999; Vol. 22, No. 3

6. Source: M. Plebani Carraro P. Mistakes in a stat Laboratory: types and frequency. Clinical Chemistry. 1997; 43:8 1348-1351

BD Diagnostics - Preanalytical Systems follow the National Committee for Clinical Laboratory Standards (NCCLS) Guidelines

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Page 8: 2006 EMA Vacutainer Cat

Finding Real Solutions

BD is the world’s leading manufacturer of safety-engineered devices and BD Diagnostics - PreanalyticalSystems is the world’s leading supplier of safetyproducts within the evacuated blood collectionmarket.

Every day thousands of healthcare workers are potentially exposed to life

threatening diseases as the result of accidents involving medical devices

critical to the care and treatment of their patients.

Needlestick and other sharps injuries present an exposure risk to hepatitis

B (HBV), hepatitis C (HCV), HIV and other blood borne pathogens, and

represent an occupational hazard to over 5.6 million workers in the

healthcare industry. BD is a pioneer in the development of safety products

designed to protect healthcare workers and is actively seeking to expand the

market for products that protect against sharps injuries.

BD has dedicated more money, human resources and technical know-how to the

task of reducing sharps injuries than any other company. With more than $500

million spent on manufacturing and R&D along with the approval of 75 new patents for

safety devices over the past 12 years, BD leads the world in providing the means for

reducing healthcare worker injuries.

BD is committed to raising awareness of risks faced by healthcare workers and the methods for increasing safety. Our

company's goal is to educate and inform institutions and the people at risk. Today, we have the most extensive array of

safety-engineered devices in the industry, including blood collection systems, syringes and infusion therapy systems, and

are the acknowledged leader in providing the newest generations of technology and educational services.

BD has launched the Safety Compliance Initiative to raise end-user

awareness of the risk of needlestick and other sharps injuries. We will

work with you to achieve your safety goals, while continuing to deliver

superior patient care. BD also provide substantial support for the

EPINetTM (The Exposure Prevention Information Network) program,

which tracks and analyses needlestick injuries. The intent of EPINetTM is

to provide healthcare facilities with a standardised method for recording

percutaneous injuries and contacts with blood and other body fluids.

With more than 65 years of providing safety-engineered devices,

educational services and value programmes designed to help prevent

occupational injury, BD recognises that engineering controls are an

effective component of an injury reduction programme.

By choosing to work with BD to transition your Trust you can select from

the widest range of safety products in the world. Our trained and

competent clinical resource consultants, experts and sales team will give

you access to the largest range of support services and specialist

education programs available in the industry. You also have the

reassurance of knowing that you working with a team of people

dedicated to offering you real solutions to the safety challenges you are

facing in the work place today.

For more information on this and other BD Safety products please contact your local BD Sales Office or visit

www.bd.com

EPINet™ is a trademark of the University of Virginia

Sterile Services 2%

HCA/NA 7%

Domestic/Porter 4%

Clinical Lab. Worker 1%

Phleb/IV Team 3%

Student 5%

SHO/HO 16%Consultant/Registrar 8%

Nurse 43%

Other 11%

Job Category of the Injured Worker

0

50

100

150

200

250

Original Purpose of the Sharp Item

Number of NSIs% of Reported Incidents

Unk

now

n /

N/A

Inje

ctio

n IM

/SC

Can

nula

te IV

or

Setu

p H

epar

inLo

ck

Ven

epun

ctur

e

Fing

erst

ick/

Hee

lstic

k

Sutu

ring

Cut

ting

Oth

er

Source: EPINet data 2002

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BD Vacutainer® Paediatric Product Range

BD Quikheel™ Incision DeviceThe safe, easy and virtually painless blood sampling device designed for heelsticks in premature infants,newborns and babies.

1 Tapered surface under BD QuikheelTM logo provides better visibility of blade location for accurate site selection.

2 Finger contoured design provides a steady and stable grip during lancet activation.

3 Instant trigger action provides a rapid automated incision of consistent depth and width that ensures desired blood flow.

4 Extra thin surgical steel blade provides the finest, cleanest surgicalincision resulting in a virtually pain-free heelstick.

5 Permanently retractable blade minimises possible injury and eliminates chance of re-use.

BD Genie™ LancetA full product line of safety-engineered capillary blood sampling devices

1 Convenient, self-contained, single-use device with no loading or special preparation required.

2 Full range of blade depths and needle gauges optimise blood flow for varying sample requirements.

3 Purple BD GenieTM is the smallest gauge single-use glucose lancet available.

4 Low trigger force makes device easier to activate.5 Ultra-sharp surgical stainless steel blades and needles allow for

exceptional patient comfort.6 One-step activation, within milliseconds, ensures a rapid precise

incision that is consistent in depth and width.7 Automatic and permanent lancet retraction minimizes possible

injury and eliminates accidental re-use.

BD Microtainer® with BD Microgard™ ClosureA full family of products for all your capillary collection needs

1 Integral collector eliminates the need for assembly.2 BD MicrogardTM closure nests securely on bottom of tube or

extender.3 8mm inner tube diameter allows for easy probe access.4 Lot number and expiration dates printed, for increased quality

control.5 Wider tube reservoir with exclusive textured inner surface

improves flow and mixability.6 Unique “twist-assist” safety BD MicrogardTM closure significantly

reduces splatter upon removal.7 Can be used with an extender to fit tube racks.8 Amber tubes are available for light sensitive analytes.

BD Neosyte™ Neonatal NeedleYour solution for paediatric venous collection

1 Single-ended needle allows small quantities of venous blood to be taken from neonates and infants, up to no specific age.

2 Butterfly wings for ease of use3 Silicone coated needle (as used on BD PrecisionGlideTM needles)

to enable smooth insertion of the needle4 Designed to prevent the needle from being pushed too far into

the patient and embedding the needle in tissue, or alternatively from being easily lost in bedding.

9

Path of blade incision follows a sweeping motion

Instantvertical

incision path

BD MicrogardTM

closure with unique‘twist assist’

8mm wide tubediameter

Integralcollector

Printed Lot Numbers, Fill Lines &Expiration Dates on tube

Textured inner service

Flatbottom

Tube extender

Silicone coatedneedle Large butterfly

wings for easeof use

Open end to allow bloodto flow into collection tube

Page 10: 2006 EMA Vacutainer Cat

BD Vacutainer® Tube Information

BD Vacutainer® blood collection tubes incorporate the latex-free BD HemogardTM closure3,which has two parts; an inner stopper and an outer protective cap. The BD HemogardTM

closure is easier to remove than conventional stoppers4, and protects the user from contactwith patients’ blood. The BD HemogardTM closure may also be removed using an automatedsystem such as PLUGGOTM (available from Clinicon UK Ltd). The BD Vacutainer® bloodcollection tubes can be recapped using secondary over-caps (also available from Clinicon UK Ltd).

The alternative to the BD HemogardTM closure is the traditional conventional stopper.

Tube Dimensions

BD Vacutainer® has 3 main sizes of tube:

13mm x 75mm 13mm x 100mm 16mm x 100mm(actual size) (actual size) (actual size)

1.8ml, 2ml, 2.5ml, 4ml, 4.5ml, 5ml, 8ml, 8.5ml, 9.5ml,2.7ml, 3ml, 3.5ml, 6ml, 7ml. 10ml.4ml, 4.3ml, 4.5ml,

5ml, 6ml.

BD Vacutainer® also offers the following tube sizes:

8mm x 100mm – 1.8ml

10.25mm x 64mm – 1.6ml, 1.8ml, 2ml, 2.7ml, 3ml

10.25mm x 120mm – 5ml

16mm x 75mm – 7ml

16mm x 125mm – 8ml

3.1990 Winner of the Industrial Designers Society of Americas “Socially Responsible Design” Award4. VS5713- A comparative Evaluation of the 16mm BD Hemogard™ Closures with Respect to User Exposure to Blood and Cap Removal and Reinsertion Forces. 09/99

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BD Vacutainer® Label Guide

Coming soon - a fresh new label

Accuracy is our first priority

At BD, we understand that misaligned labels can interfere with the reading of bar codes in automatedsystems, which can lead to system downtime, re-labelling of tubes, and unnecessary delays in specimenprocessing.

It is our goal to help you improve your laboratory's efficiency by offering solutions designed to reduce theadditional work associated with misaligned secondary labels.

To assist in this effort, all BD Vactutainer® Plus Plastic Tubes have been re-styled to include a visual guide forproper placement of secondary labelling. With proper training, the use of these patented label featuresshould help to reduce errors due to label misalignment.

This re-styling affects the unit label, shelf pack label, and case label.

The new style labelling will be introduced progressively across the BD Vacutainer® product range.

Patientinformation

CE mark

Expirydate

Lotnumber

Single-usesymbol

Drawvolume

Sterilisationindicator

Tube type andadditive

Colour-codednotch

Cataloguenumber

Page 12: 2006 EMA Vacutainer Cat

Serum Tubes

BD Vacutainer® Serum tubes are generally used for serum determinations within Clinical Chemistry and Serology. The tubes are availablein a range of sizes in both plastic and glass and can be identified by a red cap. BD Vacutainer® Serum tubes are also available with apink cap and crossmatch label for transfusion patients. (See page 18.)

BD Vacutainer® Plastic Serum tubes have the additive Silica sprayed on the inner walls of the tube to accelerate the clotting process. InBD Vacutainer® Glass Serum tubes the grain of the glass surface activates the clotting process naturally, and therefore these tubes arenot Silica sprayed.

BD Vacutainer® Serum tubes are also available with the additive Thrombin, which significantly accelerates the clotting time. An orangecap identifies BD Vacutainer® Thrombin tubes.

The minimum recommended clotting time for serum tubes for patients without anticoagulant is:

BD Vacutainer® Serum Tube (Red) - 60 minutesBD Vacutainer® Thrombin Tube (Orange) - 5 minutes

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic Serum tube with Red BD HemogardTM Closure368492 2 Silica (Clot Act) 13x75 Paper 100/1000

369032 4 Silica (Clot Act) 13x75 Paper 100/1000

368815 6 Silica (Clot Act) 13x100 Paper 100/1000

367896 10 Silica (Clot Act) 16x100 Paper 100/1000

BD Vacutainer® Plastic Thrombin tube with Orange BD HemogardTM Closure367811 6 Thrombin 13x100 Paper 100/1000

367817 5 Thrombin 13x75 Paper 100/1000

BD Vacutainer® Glass Thrombin tube with Orange BD HemogardTM Closure368925 3 Thrombin 13x75 Paper

368923 7 Thrombin 13x100 Paper 100/1000

Mixing recommendation: Plastic serum tubes should be gently inverted 1800 and back 5-6 timesCentrifugation instructions: ≤ 1300g for 10 minutes at 25ºC room temperature

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Serum tubes.12

Tub

es

Page 13: 2006 EMA Vacutainer Cat

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Serum Separator Tubes (BD SST™ II Advance)

BD Vacutainer® Serum Separation tubes are generally used for serum determinations in Chemistry. The tubes are available in a range of sizes inboth glass BD SSTTM, and plastic BD SSTTM II Advance, and can be identified by a gold cap. BD SSTTM & BD SSTTM II Advance tubes containSilica to activate clotting of the specimen, and a gel that forms a barrier between the clot and the serum after centrifugation. BD SSTTM IIAdvance tubes contain a NEW improved gel that has been developed by BD to help meet the changing needs of the laboratory. BD SSTTM

II Advance tubes are compatible with many commonly used therapeutic drugs and are therefore suitable for therapeutic drug monitoring.

BD SSTTM II Advance gel combines the following benefits for increased laboratory efficiency:• Improved analyte stability, certain therapeutic drugs were stable (more than 90% recovery) at the following conditions; 4 hours at

25ºC, 24 hours at 4ºC and 7 days at 4ºC.9

• Gel barrier integrity is maintained, eliminating the need for specialist gel transport tubes.10 There are also reduced incidents of gel globule formation and gel smearing.11

• Longer shelf life increased from 12 months to 16 months.

The minimum recommended clotting time for BD SSTTM and BD SSTTM II Advance tubes for patients without anticoagulant is 30 minutes.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic SSTTM II Advance tube with Gold BD HemogardTM Closure367957 3.5 Silica (Clot Act)/Gel 13x75 Paper 100/1000

367955 5 Silica (Clot Act)/Gel 13x100 Paper 100/1000

367953 8.5 Silica (Clot Act)/Gel 16x100 Paper 100/1000

367958 8.5 Silica (Clot Act)/Gel 16x100 Block 100/1000

BD Vacutainer® Plastic SSTTM II Advance tube with Blue BD HemogardTM Closure368966 3.5 Silica (Clot Act)/Gel 13x75 Paper 100/1000

368969 5 Silica (Clot Act)/Gel 13x100 Paper 100/1000

BD Vacutainer® Plastic SSTTM II Advance tube with Rust BD HemogardTM Closure368965 3.5 Silica (Clot Act)/Gel 13x75 Paper 100/1000

368968 5 Silica (Clot Act)/Gel 13x75 Paper 100/1000

BD Vacutainer® Plastic SSTTM II Advance tube with Clear BD HemogardTM Closure368970 5 Silica (Clot Act)/Gel 13x100 Paper 100/1000

Mixing recommendation: Serum Separation tubes should be gently inverted 1800 and back 5-6 timesCentrifugation instructions: Plastic BD SSTTM II tubes - 1300-2000g for 10 minutes at 25ºC room temperature

Please contact us for copies of BD clinical studies relating to BD Vacutainer® SSTTM & BD SSTTM II Advance tubes.9. VS5775 – Comparison of Vacutainer® SST™ II PLUS with Glass Serum Tubes for 12 Drugs. 02/0010. VS5824 – Gel Barrier Comparison of BD Vacutainer® SST™ II Plus, SST Plus and SST Plus Transport Tubes in Post Centrifugation Transportation. 02/0111. VS5781 – Comparison of Vacutainer® SST™ Tubes with Plus SST™ II Tubes for Gel Stability: Globules. 02/00 13

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Page 14: 2006 EMA Vacutainer Cat

Plasma Tubes (Heparin)

BD Vacutainer® Plasma tubes contain Sodium or Lithium Heparin and are generally used for plasma determinations in Clinical Chemistry.The tubes are available in a range of sizes in both plastic and glass and can be identified by a green cap.

The concentration of the Lithium and Sodium Heparin additive in BD Vacutainer® Plasma tubes is 17 International Units of Heparin/mlof blood. The additive in the plastic tube is spray coated on the inner wall, and in the glass tubes it is either lyophilised (2 and 3ml) orvacuum dried (5 and 7ml).

Heparin tubes can be centrifuged immediately, without the need to wait for the clotting process to be complete.

Cat. No. Vol. (ml) Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic Lithium Heparin tube with Green BD HemogardTM Closure368494 2 13x75 Paper 100/1000

368884 4 13x75 Paper 100/1000

368886 6 13x100 Paper 100/1000

367526 10 13x100 Paper 100/1000

BD Vacutainer® Plastic Sodium Heparin tube with Green BD HemogardTM Closure367869 4 13x75 Paper 100/1000

367876 6 13x100 Paper 100/1000

Mixing recommendation: Plasma tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: ≤ 1300g for 10 minutes at 25ºC room temperature

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Serum tubes.14

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Page 15: 2006 EMA Vacutainer Cat

Plasma Separation Tubes (BD PST™ II)

BD Vacutainer® Plasma Separation tubes are generally used for plasma determinations in Chemistry. The tubes are available in a rangeof sizes in both glass BD PSTTM, and plastic BD PSTTM II, and can be identified by a light green cap.

BD PSTTM & BD PSTTM II contain 17 IU/ml of Lithium Heparin to prevent coagulation of the specimen, and a gel made of an inert polymerthat forms a barrier between the cells and the plasma during centrifugation.

BD PSTTM II tubes contain a NEW improved gel that has been developed by BD to help meet the changing needs of the laboratory.

BD PSTTM II gel combines the following benefits for increased laboratory efficiency:

• Enhanced plasma purity demonstrated by a reduction in Fibrin, and in measurable white blood cells, red blood cells and platelets.12

• Extended analyte stability as most analytes are stable in the tube for 24hrs at 25ºC.13

• Recommended for the most commonly tested analytes as it is clinically equivalent to the BD PSTTM tube.14

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic PSTTM II tube with Light Green HemogardTM Closure367374 3 Li Hep/Gel 13x75 Paper 100/1000

367376 4.5 Li Hep/Gel 13x100 Paper 100/1000

367378 8 Li Hep/Gel 16x100 Paper 100/1000

Mixing recommendation: Plasma Separation tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: Plastic BD PSTTM II tubes - 1300-2000g for 10 minutes at 25ºC room temperature

Please contact us for copies of BD clinical studies relating to BD Vacutainer® PSTTM & BD PSTTM II tubes.

12. VS5924 Improved Plasma Purity of the BD Vacutainer® PST™II PLUS Plastic tubes compared to the BD PST™ PLUS Plastic Tubes13. VS5925 Extended Analyte Stability in the BD Vacutainer® PST™II PLUS Plastic Tubes14. VS5919 Comparison of BD PST™PLUS to BD PST™II for 22 chemistry analytes and 3 cardiac markers

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Page 16: 2006 EMA Vacutainer Cat

Fluoride/Oxalate Tubes

BD Vacutainer® Sodium Fluoride/Potassium Oxalate tubes are used for glucose determinations. The tubes are available in both plasticand glass and can be identified by a grey cap.

Glucose values in unpreserved blood samples decrease quickly after collection as glucose is metabolised by the blood cells. The additivescontained in BD Vacutainer® Sodium Fluoride/Potassium Oxalate tubes will stabilise glucose levels for up to 24 hrs.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic Fluoride/Oxalate tube with Grey BD HemogardTM Closure368920 2 Fluoride/Oxalate 13x75 Paper 100/1000

368921 4 Fluoride/Oxalate 13x75 Paper 100/1000

367925 6 Fluoride/Oxalate 13x100 Paper 100/1000

Mixing recommendation: Fluoride/Oxalate tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: ≤ 1300g for 10 minutes 25ºC room temperature

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Fluoride/Oxalate tubes.16

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Page 17: 2006 EMA Vacutainer Cat

Coagulation Tubes (Sodium Citrate)

BD Vacutainer® Citrate tubes are generally used for coagulation studies. The tubes are available in a range of sizes in both plastic andglass and can be identified by a light blue cap. BD Vacutainer® Citrate tubes contain Buffered Citrate solution, which is used as ananticoagulant for coagulation studies.

BD Vacutainer® Plus Citrate is the NEW clinically proven plastic Citrate tube from BD Vacutainer® systems. BD Vacutainer® Plus Citratefeatures innovative tube geometry that minimises tube headspace and associated platelet activation to optimise APTT monitoring ofunfractionated Heparin patients. You will always get a full draw with standard outside tube dimensions, even with small draw volumes.

BD Vacutainer® Plus Citrate tubes combine the following advantages:

• Clinically equivalent performance to the recognized global ‘Gold Standard’, the 4.5ml BD Vacutainer® Glass Buffered Citrate tube.7

• Clinically proven in multi-centre clinical trials for coagulation testing across all major patient populations.• Evaluated with the most widely used coagulation analytical systems.8

BD Vacutainer SystemsTM also offer glass CTAD (buffered Citrate, Theophylline; Adenosine and Dipyridamole) tubes for patient Heparinmonitoring and routine coagulation determinations.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plus Citrate tube with Light Blue BD HemogardTM Closure363047 1.8 Na Citrate (0.109M) 13x75 Paper 100/1000

363097 1.8 Na Citrate (0.129M) 13x75 Paper 100/1000

363048 2.7 Na Citrate (0.109M) 13x75 Paper 100/1000

363079 2.7 Na Citrate (0.129M) 13x75 Paper 100/1000

BD Vacutainer® Glass Citrate tube with Light Blue BD HemogardTM Closure367714 4.5 Na Citrate (0.105M) 13x75 Paper 100/1000

367704 4.5 Na Citrate (0.129M) 13x75 Paper 100/1000

BD Vacutainer® Glass Citrate tube with Light Blue Conventional Closure368927 1.8 Na Citrate (0.105M) 10.25x47 Paper 100/1000

368932 1.8 Na Citrate (0.129M) 10.25x47 Paper 100/1000

368926 2.7 Na Citrate (0.105M) 10.25x64 Paper 100/1000

368931 2.7 Na Citrate (0.129M) 10.25x64 Paper 100/1000

366575 6.0 Na Citrate (0.105M) 13x100 Paper 100/1000

366573 6.0 Na Citrate (0.129M) 13x100 Paper 100/1000

BD Vacutainer® Glass CTAD tube with Light Blue BD HemogardTM Closure367562 2.7 CTAD (0.109M) 13x75 Paper 100/1000

367599 4.5 CTAD (0.109M) 13x75 Paper 100/1000

Mixing recommendation: Citrate tubes should be gently inverted 1800 and back 3-4 timesCentrifugation instructions: Plastic Citrate tubes - 2000-2500g for 10-15 minutes at 25ºc room temperature

Glass Citrate tubes - 1500g for 15 minutes at 25ºC room temperature*

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Plus Citrate tubes.7 VS5936 Evaluation of BD Vacutainer™ Plus 2.7 and 1.8mL Sodium Citrate Coagulation Tubes Using The ELECTRA 1400c™ Analyser 11/018 VS5966 Evaluation of 0.019M BD VacutainerTM Plus Plastic and 0.105M BD VacutainerTM Glass Sodium Citrate Tubes for PT and APTT Using the Sysmex CA - 1500 Analyzer. 06/029 VS5967 Evaluation of BD VacutainerTM Plus Plastic 0.109M and 0.105M BD VacutainerTM Glass Sodium Citrate Tubes for PT and APTT using the ILACL Futura Analyzer. 06/02* Produces Platelet Poor Plasma (≤ 10,000/ul) REF: NCCLS Document H21-A2. Collection, Transportation and Processing of Blood Specimens for Coagulation Testing and Performance of Coagulation Assays, 2nd

Ed. Wayne, PA: National Committee for Clinical Laboratory Standards

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Page 18: 2006 EMA Vacutainer Cat

ESR Products

BD Vacutainer® Sedi-15 Instrument is a fully automated and closed system for the determination of the Erythrocyte Sedimentation Rate(ESR). BD Vacutainer® Sedi-15 will calculate the manual one hour and two hour Westergren readings within 27 minutes, utilising itsunique integrated mixer and digital camera. BD Vacutainer® Sedi-15 is equipped with a rack which holds 15 sterile evacuated 1.8mlBD SeditainerTM tubes, an integrated printer for immediate printed results, and a network cable allowing it to be linked with otherBD Vacutainer® Sedi-15 Instruments. A quality control start-up kit including check tubes is also available.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Glass SeditainerTM tube with Black Conventional Closure366676 1.8 Na Citrate (0.105M) 8x100 Paper 100/1000

Cat. No. Description Qty

BD Vacutainer® Sedi-15 System and Additional Equipment366076 BDTM Sedi-15 Closed Automated System 1

366041 BDTM Sedi-15 Tube Rack (holds up to 15 1.8ml tubes) 1

366072 BDTM Sedi-15 Barcode Reader 1

361520 BDTM Sedi-15 Printer Paper Roll 20

366119 Quality Performance Test Kit 1

BD Vacutainer® SedisystemTM Additional Equipment366044 BD SedisystemTM Printer Paper Roll 1

Mixing recommendation: ESR tubes should be gently inverted 1800 and back 8-10 times

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Sedi-15 instrument.18

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Page 19: 2006 EMA Vacutainer Cat

ESR Tubes (Buffered Sodium Citrate)

BD Vacutainer® SeditainerTM tubes are used for measuring the Erythrocyte Sedimentation Rate (ESR) without the need for opening atube for blood pipetting or transfer. BD SeditainerTM tubes are available in glass and are identified by a black cap. Blood is drawn directlyinto the BD SeditainerTM tube, the tube has to be mixed 8-10 times, inserted into the BD SeditainerTM Stand and the result can be readafter 60 minutes. The BD SeditainerTM stand holds up to 10 BD SeditainerTM tubes and is equipped with a unique zero level adjustmentand movable scales giving Westergren readings.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Glass SeditainerTM tube with Black BD HemogardTM Closure366674 5.2 Na Citrate (0.105M) 10.25x120 Paper 100/1000

BD Vacutainer® Glass SeditainerTM tube with Black Conventional Closure366666 5.2 Na Citrate (0.105M) 10.25x120 Paper 100/1000

BD Vacutainer® Manual ESR tube with BD HemogardTM Closure367740 1.6 Na Citrate (0.129) 13x75 Paper 100/1000

367741 2.4 Na Citrate (0.129) 13x75 Paper 100/1000

Cat. No. Description Qty

BD Vacutainer® Manual ESR SeditainerTM Stand366016 Manual BD SeditainerTM Stand 1

Mixing recommendation: ESR tubes should be gently inverted 1800 and back 8-10 times

Please contact us for copies of BD clinical studies relating to BD Vacutainer® SeditainerTM tubes.19

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Page 20: 2006 EMA Vacutainer Cat

Crossmatch Tubes

BD Vacutainer® Crossmatch tubes are used for blood transfusion patients. The tubes are available in plastic EDTA and plain clot activatortubes and in glass plain serum tubes. A pink cap and a specialised crossmatch label, which is larger than the usual block label to allowmore information to be recorded, identify BD Vacutainer® Crossmatch tubes.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic EDTA Crossmatch tube with Pink BD HemogardTM Closure366164 4 K2EDTA (Spray) 13x75 Xmatch 100/1000

367941 6 K2EDTA (Spray) 13x100 Xmatch 100/1000

BD Vacutainer® Plastic Clot Activator Crossmatch tube with Pink BD HemogardTM Closure368817 6 Silica (Clot Act) 13x100 Xmatch 100/1000

Mixing recommendation: Plastic Silica tubes should be gently inverted 1800 and back 5-6 timesEDTA tubes should be gently inverted 1800 and back 8-10 times

Centrifugation instructions: ≤ 1300g for 10 minutes at 25ºC room temperature

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Page 21: 2006 EMA Vacutainer Cat

EDTA Tubes

BD Vacutainer® EDTA tubes are generally used for whole blood Haematology determinations. The tubes are available in a range of sizesin both plastic and glass and can be identified by a lavender cap. BD Vacutainer® EDTA tubes are available with a pink cap andcrossmatch label for transfusion patients. (See page 18.)

Generally, K2 or K3 Potassic Salt of EDTA (Ethylene Diamine Tetra Acetic acid) is used as an anticoagulant. In BD Vacutainer® Plastic EDTAtubes the inner wall is spray coated with the additive, whereas in BD Vacutainer® Glass EDTA tubes the additive is in liquid form.

BD Vacutainer® Aprotinine K3EDTA tube is available for assays that require a proteolytic enzyme inhibitor. A conventional pink capidentifies BD Vacutainer® Aprotinine K3EDTA tubes.

Cat. No. Vol. (ml) Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic K2EDTA tube with Lavender BD HemogardTM Closure368841 2 13x75 Paper 100/1000

368856 3 13x75 Paper 100/1000

368861 4 13x75 Paper 100/1000

367864 6 13x100 Paper 100/1000

BD Vacutainer® Plastic K3EDTA tube with Lavender BD HemogardTM Closure367836 2 13x75 Block 100/1000

368857 3 13x75 Block 100/1000

368860 4 13x75 Paper 100/1000

Mixing recommendation: EDTA tubes should be gently inverted 1800 and back 8-10 times

Please contact us for copies of BD clinical studies relating to BD Vacutainer® EDTA tubes.21

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Page 22: 2006 EMA Vacutainer Cat

Blood Banking Tubes

BD Vacutainer® ACD tubes are generally used in Immuno-haematology or blood banking units to preserve red blood cells. BD Vacutainer® ACD tubes are available in glass only and are identifiable by a yellow cap.

BD Vacutainer® ACD tubes contain the active anticoagulant Tri-sodium Citrate with Citric Acid and Dextrose. It is available in twoformulations: ACD solution A and ACD solution B. In the ACD solution A formulation, an additive to blood ratio of 1:5.67 is usedwhereas in the ACD solution B formulation the additive to blood ratio is 1:3.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Glass ACD Solution B tube with Yellow BD HemogardTM Closure367756 6 ACD B 13X100 Paper 100/1000

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic Evacuated Secondary Tube (EST) with Transcluscent White Hemogard Closure362725 3 None 13x75 Banded 100/1000

Mixing recommendation: ACD tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: ≤ 1300g for 10 minutes at 25ºC room temperature

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Page 23: 2006 EMA Vacutainer Cat

Trace Element Tubes

BD Vacutainer® Trace Element tubes are generally used to analyse the level of certain trace elements in blood samples.

BD Vacutainer® Trace Element tubes contain minimum quantities of several trace elements. The levels of contaminants from the stopperor tube are guaranteed to a minimal level, which is listed below. Sodium Heparin tubes are used for plasma analysis and plain tubes areused for serum analysis. This information is also detailed in the product insert.

TEST µg/litre

Antimony -Arsenic 0.2Cadmium 0.1Calcium 150.0Chromium 0.5Copper 5.0Iron 25.0Lead 0.3Magnesium 40.0Manganese 1.5Mercury 3.0Selenium 0.6Zinc 40.0

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic Plain tube with Royal Blue BD HemogardTM Closure368380 6 Clot Activator 13x100 Paper 100/1000

BD Vacutainer® Plastic Sodium EDTA with Royal Blue BD HemogardTM Closure368381 6 K2EDTA 13x100 Paper 100/1000

Mixing recommendation: Trace Element tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: ≤ 1300g for 10 minutes 25ºC room temperature

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Page 24: 2006 EMA Vacutainer Cat

PPllaassmmaa PPrreeppaarraattiioonn TTuubbeess (BD PPTTM)

The PPT Plasma Preparation Tube is:• Proven for HIV and HCV screening in Blood Banks• Proven for HIV and HCV viral load testing• A closed– system for greater Safety• Eliminates manual separation and transfer steps• Provide one device Blood Collection, Transport and Storage

Isolation of plasma from whole blood is a first step for many in-vitro molecular diagnostic assays such as but not limited to PCR –polymerase chain reaction and/or bDNA – branched DNA amplification techniques. Although, one definition of plasma is “acellular”, acurrent accepted technique for plasma separation is to collect whole blood into an EDTA or ACD blood collection tube, such as the BDVacutainer® tube containing these anticoagulants. This anticoagulated blood, collected by routine phlebotomy, requires centrifugationto separate the plasma from the formed elements. Immediately after centrifugation, the tube is opened and the plasma is carefullypipetted into a separate container. The BD Vacutainer® Brand PPT™ - Plasma Preparation Tube- combines a spray-dried anticoagulantand a polyester material which separates most of the erythrocytes and granulocytes, and some of the lymphocytes and monocytes awayfrom the supernatant. Plasma prepared in a BD PPT™ tube may contain a higher concentration of platelets than the concentration foundin whole blood. The result is a convenient, safe, single tube system for the collection of whole blood and the separation of plasma.Samples can be collected, processed and transported in situ thereby reducing the possibility of exposure to bloodborne pathogens at thecollection and sample processing sites.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box/Case Qty

BD Vacutainer® Plastic PPTTM tube with BD Pearlescent White HemogardTM Closure362795 5 K2EDTA/Gel 13x100 See Thru 100/1000

362797 8.5 K2EDTA/Gel 16x100 See Thru 100/1000

Mixing recommendation: Plasma Preparation tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: 1100g for 10 minutes at 25ºC room temperature

Please contact us for copies of BD clinical studies relating to BD Vacutainer® PPTTM tubes.24

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Cell Preparation Tubes (BD CPT™)

Applications:

Immune Function Tests

Lymphocyte proliferation Assays

Metastic Tumour cell detection

HLA-typing

Genetic marker Analysis

HIV proviral testing

BD Elispot Reagents

T-SPOT (CE) (Oxford Immunotech)

This tube allows the isolation of peripheral blood mononuclear cells (PBMC’s) in just one step. It means you no longer need to labelsecondary tubes, dilute blood, layer and harvest from an open density gradient.BD™ Cell Preparation Tubes contain an anticoagulant (sodium citrate or sodium heparin), a combined gel/Ficoll separation system andare silicone coated to minimize non-specific cell activation. Blood is drawn directly into the tube (using the standard BD Vacutainer®technique) and should be processed within 24h after collection for cell based assays. During centrifugation, the PBMC’s form a layer abovethe gel; a stable, impermeable barrier to erythrocytes and granulocytes which remain below the gel barrier.After centrifugation, for optimum recovery of PBMC’s, the tube is inverted gently to resuspend the PBMC’s in the plasma. It can then beopened to transfer the cell/plasma suspension into a secondary tube e.g. for washing (pour over or pipette out). In order to obtain plasma&PBMC’s separately, the plasma can first be removed and then the cells are harvested by adding 3-5 ml washing buffer directly into theCPT tube. In addition, the CPT system offers the unique possibility to dispatch or store the PBMC’s in the primary tube after centrifugation,in which case the autologous plasma serves as the nutrient. Depending on your application the PBMC’s can then be stored up to 48 hoursat room temperature.

As a whole, the CPT system guarantees a strict standardization of PBMC’s isolation and simplifies the isolation process considerably. Theclosed, sterile system renders high sample quality and significant reduction of biohazards, cell stimulation tests, tumour cell detection,HLA-typing and nucleic acid preparation.

Cat. No. Vol. (ml) Additive Size (mm) Label Type Box Qty

BD Vacutainer® Glass CPTTM tube with Blue/Black speckled Conventional Closure362781 4 Sodium Citrate/Ficoll 13x100 See Thru 60

362782 8 Sodium Citrate/Ficoll 16x125 See Thru 60

BD Vacutainer® Glass CPTTM tube with Red/Green speckled Conventional Closure362780 8 Sodium Heparin/Ficoll 16x125 See Thru 60

Mixing recommendation: Cell Preparation tubes should be gently inverted 1800 and back 8-10 timesCentrifugation instructions: 1500-1800g for 15-20 minutes at 25ºC room temperature

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PAXgeneTM Blood RNA System

Applications & Diseases area:

· Oncology· CML (bcr/abl)· Circulating tumour deraction· Clorectan Cancer recurrence· Neurology’MS)· Inflammatory Disease (RA)· Hemostasis and Thrombosis· Diabetes

The PAXgene Blood RNA System is a revolutionary, enabling technology that consolidates and integrates the key steps of whole blood collection, nucleic acid stabilization, and RNA purification. By minimizing the unpredictabilityassociated with RNA processing, the system provides enhanced accuracy of intracelluluar RNA analysis.

The PAX gene system is standardized on convenient Bd Vauctainer technology, enhancing patient and health care worker safety, providingsample protection, and facilitating Consistent blood volumes.

The PAXgene tube contains a proprietary reagent that immediately stabilizes introcellular RNA for days at room temperature and weeksat 4ºC. The ability to eliminate freezing batch samples and minimize processing urgency, greatly enhances lab efficiency.

The PAXgene kit uses a unique version of Qiagen’s proven seperation and purification technology. The purification process is deigned toprovide high quality RNA from samples that have been stabilized in the PreAnalytix reagent.

The PAXgene Blood RNA System CE/IVD provides clinical laboratories, pharmaceutical, CRO, and research institutions with a completelyintegrated approach to RNA purification. No special kits, no uncertainty. One intergrated product from blood collection to pure RNA.

Cat. No. Description Quantity

BD Vacutainer® Plastic PAXgeneTM Blood RNA Tubes with BD HemogardTM Closure

762165 PAXgeneTM Blood RNA Tubes 100

*PAXgeneTM tubes are available from BD Diagnostics - Preanalytical Systems; the PAXgeneTM kits are availablefrom Qiagen on +21 03 291 2000.

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BDTM P100 Kit

BD P100 is an evacuated blood collection tube that contains Proprietary protein stabilizers and an innovative mechanical separator thatprovides a means for collection, separation and transportation of plasma to be used in protein analysis. This product is for research useonly and therefore the use of this product for diagnostic procedures and patient management is strictly prohibited. Neither the clinicalutility nor the performance characteristics of the tube as part of an invitro diagnostic procedure has been established.

The BD P100 tube contains spray-dried K2 EDTA as the anticoagulant and proprietary stabilizers to minimize protein degradation.During centrifugation, the mechanical separator is activated and moves into the position between the plasma and cellular elements.The mechanical separator dramatically minimizes cellular contamination. After separation, plasma may be aspirated directly from thecollection tube, eliminating the need to transfer the plasma to a secondary tube.

When using the BD P100 you would need the following equipment (not provided with the kit):1. Disposable transfer pipettes if direct sampling from the instrument is not used or if the specimen is stored separately.2. Centrifuge capable of generating 2000-3000g (RCF) at the bottom of the tube. 3. Gloves, eye protection and other personal protective equipment as necessary for protection from exposure to blood borne pathogens.

Protect Valuable Plasma ProteinsBD P100 tubes contain proprietary stabilizers that immediately solubilize during blood collection, enhancing recovery and preservationof plasma analytes:• Sterile and ready to use• No reconstitution required• No secondary transfer steps• Novel non-gel separator

BD P100 Blood Collection System ID for Research Use Only, not for use in diagnostic procedures.

Cat. No. Volume (ml) Quantity

BD Vacutainer® P100 Blood Collection

366456 8.5 12

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Page 28: 2006 EMA Vacutainer Cat

BDTM FFE

The only separation system that provides high resolution fractionation and purification across a broad mass range – from peptides andproteins to cellular organelles.

Whether you are using LC/MS to discover targets for drugs intervention or conducting large-scale 2D-PAGE proteome ID maps, the BDFree Flow Electrophoresis System provides host of Novel performance benefits that improves research results:• Continuous, Matrix-free Separation: Anlyte recovery from gels and non specific proteins losses to separation matrices are eliminated.• Ultra fine, Highly Accurate Separation Gradient: The system provides 96 discrete ph levels of 0.1 ph units or less, with separations in

less that 30 minutes. The separation quality and accuracy is truly impressive, providing highest reproducibility. The molecules are separated either based on their isoelectric points, using proprietary free-flow reagents (isoelectric focusing) or by net charge (zone electrophoresis), depending on the protocol.

• Compatibility with Downstream Applications: The BD Free Flow Electrophoresis System is easy to use and is an ideal first step in reduction of sample complexity. Its compatible with to HPLC or SDS or IEF PAGE methods, enabling access to low abundance proteins.

Key Protein Analytical Applications:

The BD Free Flow Electrophoresis System uniquely enables a multiple of applications, from plasma proteomics to organelle purification:• Human Plasma Protein Analysis• Membrane Proteins • Organelle-based Sub-proteomes

The BD Free Flow Electrophoresis System Improves research results:• Continuous, Matrix-Free Separation • Ultra Fine, Highly Accurate Separation Gradient• Compability with downstream analytical methods.

Cat. No. Quantity

BDTM Free Flow Electrophoresis System

441117 1

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Page 29: 2006 EMA Vacutainer Cat

Urine

BD Vacutainer® urine products provide a standardised system for urine collection and transportation, which offer the same benefits asa closed blood collection system. Available for urine analysis are tubes, a collection cup and a transfer straw. For Microbiology, tubes withtransfer straws and a 24 hour container are available. At the point of collection, the urine sample is transferred directly from the samplecup into an evacuated tube. BD Vacutainer® closed system for urine analysis reduces handling and minimises the risk of contact withthe specimen.

Box/Cat No Description Additive Vol (ml) Size (mm) Case Qty

Plastic Urinanalysis Tubes368500 Round Bottom/BD HemogardTM None 4 13x75 100/1000

368501 Round Bottom/BD HemogardTM None 6 13x100 100/1000

364938 Round Bottom/Conventional None 10 16x100 100/1000

364915 Round Bottom/BD HemogardTM None 11 16x100 100/1000

Plastic Microbiology Tubes364958 BD HemogardTM Closure Lyophilised Formula 4 13x75 100/1000

364959 BD HemogardTM Closure/Includes Straw Lyophilised Formula 4 13x75 50

364944 Conventional/Includes Straw Lyophilised Formula 10 16x100 50

BD Urinanalysis Tubes

365000 Conical Bottom/Conventional None 9.5 16x100 100/1000

Cat No Description Volume Box/Case Qty

Accessories364941 Plastic Specimen Collection Cup 120ml 200

364982 Plastic 24 Hour Container 3 Litres 40

364940 Transfer Straw 120ml 1000

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Urine tubes. 29

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BD EclipseTM Safety Needle

BD Vacutainer® EclipseTM needles incorporate additional safety into the traditional BD Vacutainer® blood collection needle, with noneed to change the blood collection technique. The built-in safety shield is in alignment with the bevel of the needle and can be activatedimmediately after blood collection using a one-handed continuous movement. There is no need for a work table or surface to activate it.The safety shield permanently locks into place, significantly reducing the risk of accidental needlestick injury and infection transmission.BD EclipseTM needles are compatible with all BD Vacutainer® holders and tubes. New Pre-attached holder in a sterile blister pack nowavailable for 2006.

Cat. No. Gauge Length Shield Colour Box/Case Qty

BD Vacutainer® EclipseTM Multi-sample Safety Needles368609 21g 1.25" 48/480

368610 22g 1.25" 48/480

Pre-attached BD Vacutainer® EclipseTM Safety Needles368650 21g 1.25" 1000

368651 22g 1.25" 1000

Please contact us for copies of BD clinical studies relating to BD Vacutainer® EclipseTM needles.

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Double locking mechanism

Visual indicator allows userto see the needle and showsthat safety shield has beenactivated

An audible “click” ensuresneutralisation of the needle

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Needles

BD Vacutainer® PrecisionGlideTM multi-sampling sterile needles can be used for multiple tube samples. BD PrecisionGlideTM needleshave an advanced low-angle bevel design and are coated with silicone, a low friction lubricant, ensuring very gentle and smooth veinentry. Individual laser quality control maintains the highest quality levels and a unique polishing process makes BD PrecisionGlideTM theworld’s leader in sharpness. BD PrecisionGlideTM multi-sampling needles are available with a 20, 21 or 22 gauge needle.

Veterinary needles are available with an 18 or 20 gauge needle.

BD Vacutainer® Luer adapters are sterile devices with a multi-sampling value and are designed for use with a catheter or hypodermicneedle to collect blood with BD Vacutainer® blood collection tubes. They are also ideal for use with any female luer fitting.

Cat. No. Gauge Length Shield Colour Box/Case Qty

BD Vacutainer® PrecisionGlideTM Multi-sample Needles360210 22g 1" 100/1000

360211 22g 1.5" 100/1000

360212 21g 1" 100/1000

360213 21g 1.5" 100/1000

360214 20g 1" 100/1000

360215 20g 1.5" 100/1000

BD Vacutainer® Single-sample Needles (Veterinary)360745 20g 1" 100/1000

360746 20g 1.5" 100/1000

360747 18g 1" 100/1000

360748 18g 1.5" 100/1000

BD Vacutainer® Luer Adapter367300 N/A N/A 100/1000

BD Vacutainer® Flashback Needle301746 21g 1" 50/1000

361747 22g 1" 50/1000

361748 22g 1.25" 50/1000

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Blood Collection Sets

BD Vacutainer® Safety-LokTM Blood Collection Sets are sterile closed systems for drawing blood from difficult veins, such as the back ofthe hand, and minimise the risk of false positives in the case of collection of blood cultures. BD Safety-LokTM Blood Collection Sets havean integrated protective shield, which permanently locks over the needle after venepuncture. BD Safety-LokTM Blood Collection Setshave proven their efficiency in the reduction of needlestick injuries, dividing the risk by 10.15

BD Safety-LokTM Blood Collection Sets are available with a 21, 23 or 25 gauge needle and have a range of latex-free flexible tubinglengths. They incorporate larger butterfly wings for ease of use.

Cat. No. Gauge Length Colour Box/Case Qty

BD Vacutainer® Safety-LokTM Blood Collection Sets367282 21g 0.75", 7" tubing 50/200367286 21g 0.75", 12" tubing 50/200367284 23g 0.75", 7" tubing 50/200367288 23g 0.75", 12" tubing 50/200367295 25g 0.75", 7" tubing 50/200

BD Vacutainer® Push Button Collection Sets367338 21g 0.75", 7" tubing 50/200367336 23g 0.75", 7" tubing 50/200367335 25g 0.75", 7" tubing 50/200367344 21g 0.75", 12" tubing 50/200367342 23g 0.75", 12" tubing 50/200

Pre-attached BD Vacutainer® Safety-LokTM Blood Collection Sets368652 21g 0.75", 12" tubing 25/200368654 21g 0.75", 7" tubing 25/200368655 23g 0.75", 7" tubing 25/200

BD Vacutainer® Valu-SetTM

387465 19g 0.75", 12" tubing 100/2000387455 21g 0.75", 12" tubing 100/2000387445 22g 0.75", 12" tubing 100/2000387435 23g 0.75", 12" tubing 100/2000387425 25g 0.75", 12" tubing 100/2000387423 25g 0.50", 12" tubing 100/2000387412 27g 0.38", 12" tubing 100/200015. Les Accidents d’Exposition au Sang aux HCL en 1998 – article; CDC – Prevention of NSI’s in HCW’s, 03/2000

Translucent shield allowsuser to see the needle

Larger wingsfor ease of use

Audible ‘click’ confirmsneutralisation of the needle

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Page 33: 2006 EMA Vacutainer Cat

Holders and Adapters

BD Vacutainer® single-use holders are compatible with all BD Vacutainer® tubes and needles, including BDEclipseTM Safety Needles and BD Safety-LokTM Blood Collection Sets. BD Vacutainer® single-use holders are alsocompatible with BD BACTECTM blood culture bottles. BD Vacutainer® Systems now offer the BD Vacutainer®

One Use holder. The holder clearly states “SINGLE USE ONLY” making it easy to identify as a disposable device. BD Vacutainer® One Use holders are compatible with all BD Vacutainer® tubes and needles, as well as BDBACTECTM blood culture bottles.

BD Vacutainer® Systems now offer two multiple sample adapters. The BD Vacutainer® Direct Draw Adapter is amultiple-sample Luer adapter with pre-attached holder. It can be used for transferring blood from an arterial line orwith any female Luer fitting into an evacuated tube or blood culture bottle. The BDVacutainer® Blood Transfer Device is a pre-assembled and easy-to-use device designedwith safety in mind. It is used for needleless specimen transfer from a syringe to anevacuated tube or blood culture bottle.

Both adapters offer the following benefits:

• Individually packaged and sterile for use when a sterile holder is necessary.• Safe as they are closed systems reducing the risk of transfer related injuries.• Single-use eliminating the risk of contamination.

Cat. No. Description Colour Box/Case Qty

Holders for use with Vacutainer® Multi Sample Needles364815 One Use holder (Imprinted Single-use Only) White 250/1000

Holders with Attachments364810 Blood Transfer Device (with Female Luer Adapter) Yellow 50/200

364896 Direct Draw Adapter (with Male Luer Adapter) Yellow 50/200

Holders with Attachments368487 BD Vacutainer Catheter Blood Collection Set 40/320

- standard adapter with tubing

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Blood Transfer Device.

1. 364810

2. 364896

3. 364815

4. 368487

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364815

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Page 34: 2006 EMA Vacutainer Cat

BD Microtainer® Tubes

BD Microtainer® tubes are used for the collection and centrifugation of capillary blood from skin puncture. BD Microtainer® tubes come with a variety of additives for various tests, have visible fill lines and are all colour-coded as standard BD Vacutainer® tubes making them easy to identify. There are also amber tubes available for light sensitive analytes. BD Microtainer® labels are available from BD Customer Services Department.BD Microtainer® tubes with BD Microgard® closure have an integrated collection scoop, along with a wider diameter (8mm) for easeof collection and improved mixing ensuring a quality sample is collected. Additionally, the BD Microgard® closure helps protect thehealthcare worker from exposure to potentially infected blood with the “twist assist” cap making removal safer. These tubes hold 250µl– 500µl of blood. BD Microtainer® tubes with BD Microgard® closure can also be used with a tube extender to increase the length to75mm, for use in 13mm x 75mm racks.BD Microtainer® tubes are also available with Flotop collector and closure plug. These hold 200µl – 600µl of blood.

Cat. No. Additive Cap Colour Box/Case Qty

BD Microtainer® tube with BD MicrogardTM Closure365964 Plain 50/200

365968 BD SSTTM Clot Activator/Gel 50/200

365979 BD SSTTM Amber Clot Activator/Gel 50/200

365975 K2EDTA 50/200

365966 Lithium Heparin 50/200

365986 BD PSTTM Lithium Heparin/Gel 50/200

365988 BD PSTTM Amber Lithium Heparin/Gel 50/200

365993 Sodium Fluoride EDTA 50/200

Cat. No. Description Colour

BD Microcollection Accessories368933 Extender for Microtainer® with BD MicrogardTM 50/200

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Microtainer® tubes with BDMicrogardTM closure.

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Capillary Sampling

BD Pre-analytical Systems supply a range of lancets for capillary blood collection.

BD GenieTM lancets are single-use, ready-to-use safety-engineered lancets, which can be used for both heel and finger puncture. BDGenieTM lancets use ultra-sharp surgical stainless steel blades and needles that are instantly activated and permanently retracted, designedto give maximum blood flow with minimum pain. BD GenieTM lancets are available in five different sizes; the orange and newly availablepurple are needles ideal for glucose monitoring, and the pink, green and blue are blades which are generally used for paediatric sampling.

BD QuikheelTM incision devices are safe, easy and virtually painless blood sampling devices designed for heelsticks in premature infants,newborns and babies. The BD QuikheelTM design uses a sweeping motion which minimises pain for the patient. They have an instanttrigger action that provides a rapid automated incision of a consistent depth and width that ensures superior blood flow. The extra thinsurgical steel blade is permanently retractable, minimising the possibility of injury and preventing re-use.

Cat. No. Lancet Type Colour Depth (mm) Blood Volume Box/Case Qty

BD Genie™ Single-use Safety Lancet366584 Blade 1.00 Low 200/2000

366585 Blade 1.50 Medium 200/2000

366586 Blade 2.00 Medium to High 200/2000

366587 Cannula 2.25 Single Blood Drop 200/2000

366588 Cannula 0.40 Single Blood Drop 200/2000

BD Quikheel™ Single-use Safety Incision Device368102 Blade 1.75 Medium to high 50/200

368103 Blade 2.50 High 50/200

Please contact us for copies of BD clinical studies relating to BD Vacutainer® QuikheelTM lancets.35

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Page 36: 2006 EMA Vacutainer Cat

Critical Care Collection

BD Vacutainer® Critical Care blood collection syringes can be used to measure arterial blood gases and other critical care tests. They aresterile plastic syringes, all of which are latex-free. They contain calcium-balanced Heparin that enables the specimen to be analysed forABG’s and a host of critical care analytes.

BD Vacutainer® PresetTM syringes are used for critical care testing on whole blood. The syringe plunger can be preset to a desiredvolume. As arterial blood fills the syringe, the residual air is expelled through the self-venting membrane.

BD Vacutainer® A-LineTM syringes are used for full panel critical care testing by manual aspiration. They can be used for arterial or venousblood collection from an arterial or I V line, and exist in 1ml slip tip, 3ml slip tip and 3ml BD Vacutainer® Luer-LokTM syringes.

A BD HemogardTM type tip cap is available on all 3ml syringes with BD Luer-LokTM. The screw lock ensures a tight seal even duringtransportation, offering a leak proof and airtight sample.

BD Vacutainer® EclipseTM safety needles for arterial blood collection are available offering enhanced safety for the healthcare worker.The safety shield is integrated and is not an accessory to the needle. The needle bevel and safety shield are in alignment, ensuring noextra manipulation. The one-handed technique ensures no change in the collection technique and the double-locking mechanism is bothvisually and audibly confirmed for the healthcare worker.

Tests that can be conducted using BD Vacutainer® Critical Care blood gas syringes:

Cat. No. Description Vol. (ml) Qty

Aspiration Sampling Technique without Needle364356 BD A-LineTM Slip Tip 1 100

364378 BD A-LineTM BD Luer-LokTM BD HemogardTM 3 100

364376 BD A-LineTM Slip Tip 3 100

Automatic Fill Sampling Technique without Needle364416 BD PresetTM Slip Tip 1 100

364316 BD PresetTM BD Luer-LokTM BD HemogardTM 3 100

Automatic Fill Sampling Technique with Needle364413 BD PresetTM Slip Tip 23g x 1" 1 100

364415 BD PresetTM Slip Tip 25g x 1" 1 100

364327 BD PresetTM BD Luer-LokTM BD HemogardTM 23g Needle 3 100

364390 BD PresetTM BD Luer-LokTM BD HemogardTM 22g BD EclipseTM 3 100

364391 BD PresetTM BD Luer-LokTM BD HemogardTM 23g BD EclipseTM 3 100

364393 BD PresetTM BD Luer-LokTM BD HemogardTM 25g BD EclipseTM 3 100

Please contact us for copies of BD clinical studies relating to BD Vacutainer® Critical Care syringes.36

Critical Care Panel

PO2PCO2chloridePHBUN

lactatehaemoglobinsodiumpotassium

iCaiMgcreatinineglucose

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BD Vacutainer® Systems offer the choice of two types of tourniquet - BD Vacutainer® ProntoTM reusable tourniquet and BDVacutainer® StretchTM latex-free single-use tourniquet. As the BD StretchTM tourniquet is single-use, patients do not come into indirectcontact with each other, minimising the risk of infection. Diseases such as Hepatitis B, Hepatitis C and methicillin-resistant staphylococcusaureus (MRSA) are all possible through repeated use of one tourniquet. As well as the safety benefits the BD StretchTM tourniquetprovides, it is packaged in an easy-to-use dispenser, which is also convenient for storage purposes.

BD Vacutainer® Systems offer a needle disposal container and self adhesive bracket for safe needle disposal. BD Vacutainer® Systemsoffer the DIFF-SAFE® blood dispenser, which can be used to get a drop of blood from a tube without removing the cap, making it idealfor a blood smear.

Cat. No. Description Box/Case Qty

BD Vacutainer® Tourniquets367204 BD StretchTM Latex-Free Single-use Use Tourniquet 25/500

367218 BD ProntoTM Reusable Tourniquet Single

BD Vacutainer® Sharps Disposal Box367202 Needle Disposal Box 0.70 litre 50

366201 Self Adhesive Bracket for Needle Disposal Box 10

BD Vacutainer® Miscellaneous products368697 Blood Collection Tray (holds up to 80 tubes) 21

366005 DIFF-SAFE® Blood Dispenser 1000/10000

36488760 E.Zee Caps for 16mm Closure (Blue) 2500

DIFF-SAFE® is a registered trademark of Alpha Scientific Corporation

Page 38: 2006 EMA Vacutainer Cat

Re-Order Number Index

38

367896 12367811 12367817 12368492 12368815 12368923 12368925 12369032 12

Serum

367953 13367955 13367957 13367958 13368965 13368966 13368969 13368970 13

SST

367526 14367869 14367876 14368494 14368884 14368886 14

Plasma

367374 15367376 15367378 15

PPT

363047 17363048 17363079 17363097 17366573 17366575 17367562 17367599 17367704 17367714 17368926 17368927 17368931 17368932 17

Coagulation

367925 16368920 16368921 16

Fluoride/Oxalate

361520 19366016 18366041 19366044 19366074 19366076 19366119 19366666 18366674 18366676 18367740 18367741 18

ESR

367836 21367864 21368841 21368856 21368857 21368860 21368861 21

EDTA

362725 22367756 22

ACD

364915 29364938 29364940 29364941 29364944 29364958 29364959 29365982 29365000 29368500 29368501 29

Urine

368609 30368610 30368650 30368651 30

Eclipse

366164 20367941 20368817 20

Crossmatch

368380 23368381 23

Trace Element

362780 25362781 25362782 25

CPT

362795 24362597 24

PPT

762165 26PAXgene

366456 27P100 Kit

441117 28FFE

360210 31360211 31360212 31360213 31360214 31360215 31360745 31360746 31360747 31360748 31361746 31361747 31361748 31367300 31

Needles

364810 33364815 33364896 33368487 33

Holders andAdapters

364316 36364327 36364356 36364376 36364378 36364390 36364391 36364393 36364413 36364415 36364416 36

Critical CareCollection

365964 34365966 34365968 34365975 34365979 34365986 34365988 34365993 34368933 34

Microtainers

36488760 37366005 37366201 37367202 37367204 37367218 37368697 37365821 37365851 37365855 37365856 37365877 37365878 37

Accessories

366584 35366585 35366586 35366587 35366588 35368102 35368103 35

CapillarySampling

367282 32367284 32367286 32

BloodCollection

367288 32367295 32367335 32367336 32367338 32367342 32367344 32368652 32368654 32387412 32387423 32387425 32387435 32387445 32387455 32387465 32

Safety BloodCollection

Page 39: 2006 EMA Vacutainer Cat

Product Quality Statement

Product GMP Compliance

BD Vacutainer® blood collection products produced at BD, Plymouth, UK, comply with approved specifications and satisfy the essentialrequirements of the Medical Device Directive (MDD) 93/42/EEC Annex V Section3.2. The Plymouth facility is certified to ISO 9001 (ISO9000/2000 effective December 2003) and EN 46001 (ISO 13485 effective December 2003).

BD HardpakTM III blood collection needles, BD Vacutainer® Blood Collection Sets, BD Safety-LokTM Blood Collection Sets, BD SafetyFlowTM Lancets, BD MicrolanceTM and Arterial Blood Gas Syringes (with needle), are regulated by the Medical Devices Directive and areclassified as Class IIa devices. The BD Vacutainer® brand needle holder is a Class I medical device under the Medical Device Directive93/42/EEC. All of these products carry the CE marking, certified by the British Standards Institution as the Notified Body. The needlescomply with the appropriate sections of BS EN 6009.

All systems are in place to ensure compliance to IVD Directive 98/79/EC which was introduced in June 2000.All graphic symbols used on the BD Vacutainer® packaging are in compliance to EN 980.

The product shelf life is based on data from stability testing and varies according to specific products. All expiry dates are guaranteed tothe end of the month stated on the product.

BD conduct clinical testing on all products prior to release. Information relating to clinical performance can be obtained on the internetor by special request to BD.

Product sterilisation

All products are sterilised using gamma irradiation in accordance with ANSI/AAM/ISO 11137 - 1995 “Sterilisation of Health Care Products(Requirements for Validation and Routine Control - Radiation Sterilisation) of Ethylene Oxide (EtO)” in accordance with ISO 11135 - 1994“Validation and Routine Control of Ethylene Oxide Sterilisation”. Microbiological environmental assessment for bio-burden levels isconducted weekly.

The sterilisation of BD Vacutainer® products is controlled by European Standards:

EN 550 : 1994 “Sterilisation of medical devices - Validation and routine control of ethylene oxide sterilisation”EN 552 : 1994 “Sterilisation of medical devices - Validation and routine control of sterilisation by irradiation”EN 554 : 1994 “Sterilisation of medical devices - Validation and routine control of sterilisation by moist heat”EN 556 : 1995 “Requirement for terminally sterilised devices to be labelled “STERILE”

Quality System

BD, Plymouth, UK, run systems certified to ISO 9001 (ISO 9000/2000 effective December 2003). A programme of internal and externalaudits is in operation to continuously assess and improve our systems, and the suitability of our suppliers.

British Standards Institution(BSI) - Certificate ofRegistration - Compliance withBS EN ISO 9001 : 2000(effective February 2004)

BSI - EC - Certificate accordingto the requirements of CouncilDirective 93/42/EEC, Annex V,Section 3.2. - Compliance withBS EN ISO 9002 (ISO 13485effective December 2003) andEN 46002 (ISO 13488 effectiveDecember 2003).

BSI - EnvironmentalManagement System -Certificate of Registration -Compliance with ISO 14001 :1996

39

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Additional InformationRelevant Symbols:

40

The CE mark symbol; sometimes followed by acertified body number

REF Catalogue or Re-order number

STERILE R

STERILE EO

C

C

STERILE

Use by, Expires orBest Before

Read Instructionleaflet before use

Sterilised by moistheat

Protect fromsunlight (may showtemperature range)

Fragile

This way up

Date of manufacture

Protect from anylight source

Lot number or Batchnumber

Use once or Do notreuse

Sterilised byirradiation

Sterilised byEthylene Oxide gas

Storage temperaturerange

SN

K2EK3EN2E9NC4NCFXFEFHLHNHZ

EDTA - dipotassium salt

EDTA - tripotassium salt

EDTA - disodium salt

Serial number

Tri-Sodium Citrate 9:1

Tri-Sodium Citrate 4:1

Fluoride and Oxalate

Fluoride and EDTA

Fluoride and Heparin

Lithium Heparin

Sodium Heparin

None (No Additive)

BD Diagnostics - Preanalytical Systems conform to the following standards:

Unless noted otherwise, BD, BD Logo and all other trademarks are property of Becton Dickinson andCompany. © 2004 BD.

Recycle

Page 41: 2006 EMA Vacutainer Cat

41

Becton Dickinson EMA General Conditions of Sale

2006/7 EDITION

1. General

1.1 The General Sales Conditions shall apply to all offers (including offers by means of pro forma invoices), acceptances of purchase orders, sales, and deliveries of BDI.

1.2 The General Sales Conditions shall be deemed accepted by the Buyer if Buyer hasnot in writing clearly objected to them.

1.3 BDI objects to any general terms and conditions of the Buyer.1.4 All sales shall be non-exclusive and shall not confer any distribution or agency

rights unless otherwise specifically agreed.

2. Offers, oral statements and amendments

2.1 All offers by BDI shall be subject to alterations without prior notice. Any offer ofBDI shall be deemed withdrawn if it has not been accepted within the period therementioned or within fourteen (14) days after its issue.

2.2 Any oral statement, addition or amendment to the General Sales Conditions and/orthe documents of the related transaction shall only become valid if confirmed by BDI in writing.

3. Purchase orders

3.1 Any purchase order shall be subject to BDI's approval but, however, may be accepted impliedly by simply effecting delivery.

3.2 Any purchase order shall identify the country of final destination.3.3 Products may normally be expected to be available, ready for shipment, within

reasonable time from BDI's acceptance of a purchase order but delivery, however,remain subject to BDI's manufacturing capabilities.

3.4 Any purchase order shall be of a minimum amount of 2,500.- US dollars. The Buyer placing a purchase order below such minimum value shall pay to BDI a handling charge of 250 US dollars.

4. Prices

4.1 All quotations of prices are in US $ except as otherwise provided for in BDI's offerplus, even if not so mentioned in the respective offer, taxes or other charges as provided for by the applicable law.

4.2 The price payable by the Buyer for the products delivered shall be BDI's current price list which is effective at the date of delivery.

5. Payment

5.1 Payment shall become due at the date shown on the invoice or, if not mentioned, within 30 days net of the invoice's date.

5.2 Delayed payments shall bear interest of 1,5 % per month which shall be paid by the Buyer to BDI and Buyer shall additionally reimburse BDI all costs and damagesassociated with delayed payment, legal expenses included.

5.3 In no event shall the Buyer have the right to retain or set off payments unless BDIconsented thereto in writing or a final and binding court decision confirms Buyer'sclaim.

5.4 If payment shall be effected by a letter of credit, BDI's Letter of Credit Policy shallapply.

6. Delivery and risk

6.1 Any delivery of BDI shall be “ex-works” (Incoterms 1990). However, on Buyer’srequest, BDI may provide, at Buyer’s exclusive risk and cost, for transportation, legalisation, inspection, and any handling charges on usual terms.

6.2 If BDI has notified Buyer that the Products ordered are ready to ship, Buyer shalltake delivery without delay failing which all cost for storage and risk of loss or damage shall be for Buyer's account.

6.3 Products are normally available within the time frame given in the purchase orderas accepted but, however, remain subject to manufacturing capabilities and schedules as well as transportation facilities.

6.4 On BDI's request Buyer shall furnish customs clearance or any other documentation pertinent to the transaction.

7. Warranty

7.1 All products delivered shall be in compliance with the applicable specifications forthe respective period of their shelf life.

7.2 In case of products being instruments the warranty shall be twelve (12) months from the installation date at the ultimate customer's facility but in no event to exceed eighteen (18) months as of delivery to the Buyer. However, any instrumentwarranty shall only be given on the condition that the respective warranty and installation certificate of Becton was properly completed by Buyer.

7.3 The warranty shall neither cover products damaged in transit nor when the Buyeris in default of acceptance. Mishandling, repairs or alterations of products withoutBDI's authorisation shall render any warranty void.

7.4 Any defects of products which would be apparent on reasonable inspection must be notified to BDI in writing within 72 (seventy-two) hours of reception of them by the Buyer failing which the products shall irrevocably be deemed accepted by the Buyer.

7.5 Save as expressly provided for in this clause BDI shall have no liability or responsibility to the Buyer in respect of defective products and all warranties regarding the quality, condition, durability, merchantability, fitness for purpose, conformity with samples, or likewise are hereby expressly excluded.

7.6 Any warranty claim shall be in writing, using BDI's applicable complaint form, and identify the defects and their presumable cause.

8. Retention of title

BDI reserves title to all products supplied to Buyer until such time as payment for therelevant delivery has been fully received by BDI.

9. Liability

9.1 Notwithstanding mandatory provisions of any applicable law, BDI shall neither beliable for indirect or consequential damages nor for any other damages unless thelatter were caused by BDI's gross negligence or wilfulness.

9.2 BDI shall in no event be liable for any damage if it cannot be excluded that a faultof the Buyer or of a person for whom the Buyer is responsible caused the damageincluding, not limited to events identified in section 7.3 above.

10. Force Majeure

Neither party shall be liable for any breach of any agreement governed by the GeneralSales Conditions to the extent that this is caused by Force Majeure circumstances i.e.events which are beyond the reasonable control of the affected party, such as, but notlimited to, acts of god, strikes, work to rule, governmental acts, fire, flood, bad weatherconditions, war, shortfall of raw materials, energy, transportation, regardless of whetherthese were unforeseeable or not.

11. Termination

Any agreement governed by the General Sales Conditions may be terminated by BDIwith immediate effect if:(i) without requirement for BDI to any further notice, the Buyer fails to pay at due

dates, or(ii) the Buyer is in material breach of any other term or condition of the General Sales

Conditions including the related agreement and has not remedied such breach within fifteen (15) days of having been notified of such breach, or

(iii) the Buyer shall be or become bankrupt or insolvent or if there are instituted by oragainst it proceedings in bankruptcy or under insolvency laws or for its reorganisation, receivership, liquidation, dissolution or change of ownership.

12. Amendments

The General Sales Conditions including any related agreement shall not be changed ormodified except by written agreement duly signed by BDI and Buyer.

13. Applicable Law and Jurisdiction

The General Sales Conditions and any related transaction shall be governed andconstrued in accordance with the material law of Belgium except its choice of lawprinciples and the United Nations Convention on Contracts for the International Saleof Goods of April 11, 1980 and the exclusive venue of any dispute relating to theGeneral Sales Conditions or the transactions contemplated herein shall be the Courts ofAalst.

14. Anti-boycott legislation

Any agreement referring to the General Sales Conditions in conflict with US anti-boycott or any other applicable anti-boycott legislation shall be resolved first by doingthe necessary to conform with the applicable anti-boycott provisions, including, notlimited to, amending such agreement and, if that does not resolve the conflict, theviolating agreement shall be null and void as if it had never come into existence.

15. Severability

Should any part, term or provision of the General Sales Conditions be declared by anycourt to be or be accepted by the parties as being in conflict with the law orunenforceable the validity and enforceability of the remainder of the General SalesConditions shall not be affected thereby. The offending part or provision shall bereplaced by an enforceable and valid part or provision of which the economic intent isas far as possible the same.

16. Trade Compliance.

BD and ‘customer’ agree to comply fully with all laws governing trans-border sales, re-sales, shipments and transfers of Products, Original Product or End Product, includingbut not limited to the export control laws of the United States and of any othercountries, to the extent that such laws are applicable to the parties or the Product,Original Product or End Product. In this regard:- BD’s obligation to supply Product or Original Product to ‘customer’ is contingent

upon receiving any required governmental authorizations. Upon BD’s request, ‘customer’ agrees that it will furnish all information and documentation necessary for BD to obtain such authorizations.

- ‘Customer’ agrees to comply with all conditions and destination control statements set forth on the invoice, bill of lading or other documents accompanying the shipment of BD Products or Original Products.

- ‘Customer’ affirms that it will not knowingly use, resell or distribute Product, Original Product or End Product, directly or indirectly, for the development, production or proliferation of weapons of mass destruction (nuclear, chemical, or biological) or missile delivery systems, and/or for terrorist activities.

Page 42: 2006 EMA Vacutainer Cat

BD Vacutainer® Notes

BD Sales Specialist...........................................................................

Contact Details................................................................................

Page 43: 2006 EMA Vacutainer Cat
Page 44: 2006 EMA Vacutainer Cat

BD Diagnostics Preanalytical SystemsEast Europe, Middle East & Africa21 Between Towns RoadCowleyOxford OX4 3LYUnited Kingdom

Tel: +44 (0)1865 748844Fax: +44 (0)1865 781528

[email protected]

MC117

Representation Offices

BD - Russia Krasnopresenskay, Naberezhnaya 18, Block 1, Floor 8 Tel: 70 95 775 85 82123 317 Moscow, Russia Fax: 70 95 775 85 83

BD - Poland Krolowej Marysienki 90 Tel: 48 22 651 75 8802-954 Warsaw, Poland Fax: 48 22 651 75 89

BD - Hungary Szerena Ut 60/C Tel: 36 1 345 70901025 Budapest, Hungary Fax: 36 1 345 7093

BD - Dubai Arif & Bintoak Building, 1st Floor, Karama Tel: 971 4 33 79 525Zabeel Road, P.O. Box 52279, Dubai, U.A.E. Fax: 971 4 33 79 551

BD - Saudi Arabia Technical Scientific Office Tel: 966 1 278 95 81PO Box 270222, Riyadh 11352, Saudi Arabia Fax: 966 1 278 96 37

BD - Turkey Büyükdere Cad. Üçyd Mevki, Noramin Is Merzeki No. 55 Tel: 90 212 328 27 20K. 1/105 80670 Maslak, Istanbul, Turkey Fax: 90 212 328 27 30

BD - South Africa Woodland Office Park, Building 12, 2nd Floor Tel: 27 11 60 22 62020 Woodlands Drive, Woodmead 2199, South Africa Fax: 27 11 80 04 05 44

BD - East Africa Africa Re Centre, Hospital Road, Upper Hill Tel: 254 20 27 38 339P.O. Box 76613 Nairobi-0058, Kenya Fax: 254 20 27 38 342

BD - West Africa 11 Rue Aristide Berges, Al des Iles Tel: 33 476 683 23338800 Pont de Claix, France Fax: 33 476 683 495

BD International Laagstraat 57 Tel: 32 3 710 35 55Branch of BD B.V. 9140 Temse, Belgium Fax: 32 3 711 12 90