Your Power for Health

VACUETTE®

Blood Collection Tubes

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additive description item numberfill range

additive code

CE marknominal volume sterile “R” expiration date

single use only

lot number

fill mark additive description item number

additive code

CE marknominal volume sterile “R” expiration date

single use only

lot number

VACUETTE® Blood Collection Tubes have an optimal fill mark on every tube label indicating the proper volume of blood-to-additive ratio. The fill mark assists in a visual control of the specimen volume.

Nominal volume indicates the draw volume plus the additive volume contained in the tube. Fill tolerance of the VACUETTE® tube is within +/- 10% of the stated nominal volume in accordance with ISO and CLSI.

Sodium citrate tube labels have an arrow to indicate the fill range where the sample volume will yield the necessary 9:1 blood-to-additive ratio.

All tubes are FDA 510(k) cleared and carry the CE mark indicating compliance with essential requirements of the relevant European health safety and environmental protection legislation.

All labels are color coordinated with the cap and conform to ISO 6710 standards.

LABELS

HISTORY

Carl Albert Greiner founded a pressed cork production facility in Kremsmuenster, Austria in 1868 which quickly developed into other technologies for the food packaging industry. Injection molding capabilities lead to the development of the first plastic Petri dish, positioning Greiner Bio-One as a major plastics innovator in the medical market.

Increasing demands for safety in the healthcare industry lead Greiner Bio-One to introduce the first plastic blood collection tube in 1985. Development of innovative products continued including the VACUETTE® ‘sandwich’ (tube-within-a-tube) coagulation tube and many safety products used for specimen collection.

Today, Greiner Bio-One is a leader in the clinical diagnostic, pharmaceutical, research and biotechnology industries.

VACUETTE® Blood Collection Tubes are supplied to customers around the world from four manufacturing sites including Monroe, North Carolina for the North American market.

VACUETTE® Blood Collection Tubes

S TA N D A R D T U B E

COAGULATION TUBE

PEDIATRIC AND LOW VOLUME TUBES

Greiner Bio-One developed the VACUETTE® ‘sandwich’ coagulation tube in 1996. This extremely complex, patented double-wall technology combines two types of plastic.

The inner tube is made of polypropylene (PP)

PP prevents the gradual evaporation of the sodium citrate additive to maintain the correct blood-to-additive ratio.

The outer tube is made of polyethylenetherephthalate (PET)

PET maintains vacuum for maximum shelf life –12 months from the date of manufacture.

Low volume or pediatric tubes are 13x75mm tubes with draw volumes of 2.5ml or less. Low volume tubes are designed to minimize the amount of blood collected from critical, pediatric and frequently drawn patients.

Low volume tubes are manufactured from PET plastic to the same specifications as standard VACUETTE® Tubes.

Shelf life - 12 months from the date of manufacture for most additives.

Tubes are evacuated and typically contain spray-dried additives to achieve optimal blood-to-additive ratios for reduced collection volumes.

Injection molded from polyethylenetherephthalate (PET) – produces highly transparent, virtually unbreakable blood collection tubes.

Shelf life - 18 months from the date of manufacture.

Thick tube walls ensure tube integrity in extreme temperature variations.

Additives are spray-dried on the inside of the tube wall for disbursement and mixing optimization.

Tubes are evacuated according to the blood volume specification to ensure the correct blood-to-additive ratio.

All VACUETTE® Blood Collection Tubes are sterile and latex free

safety cap tube label gel

Pediatric Draw (<2ml) Sodium HeparinGel SeparationStandard Draw

Designed to minimize the spraying of aerosols during decapping and can be used to recap the tube several times. The recessed cap reduces the incidence of contact with residual blood after sampling.

The VACUETTE® safety cap used on coagulation tubes is designed with a two-step stopper to seal the inner and outer tube for a longer shelf life.

Comprised of three components (cap, ring, stopper) for strength and stability.

Short cap allows for more bar code label space on tube and fewer ID rejections/errors.

Color-coded rings identify the draw volume, or indicate the presence of gel or sodium heparin.

SAFETY CAPS

For Standard Tubes For Coagulation Tubes

TUBE SIZES

VACUETTE® Blood Collection Tubes are available in various draw volumes, including pediatric volumes of 1-2.5ml, and a variety of tube sizes.Reference the product catalog for a complete listing of tubes.

0743003R2Greiner Bio-One 888.286.3883 Phone | 800.726.0052 Fax | office@us.gbo.com | gbo.com/preanalytics

Quality Management System

ISO 9001: 2008

ISO 13485: 2003 + AC:2009 Medical Device

ISO 6710 – Venous Blood Specimen

CLSI for tubes and additives

21 CFR part 820 – FDA Quality System – Good Manufacturing Practice (GMP)

Sterilization of Health Care Products

ANSI/AAMI/ISO 11137-X

EN 556-1

European

93/42/EEC MDD

98/79/EC IVDD

Greiner Bio-One Quality Standards

Environmentally Friendly:

Implementation of the use of Green Seal® chemical products throughout the facility which are less hazardous and more concentrated than most commercial cleaning products.

Landfill Reduction:

Use of PET plastic which reduces to just 0.05% ash after incineration.

Purchasing paper products which use less packaging and are not wasted by the end user.

Recycling plastics created in the manufacturing process to reduce landfill waste.

Implementation of formal cardboard, paper, plastic and aluminum recycling program throughout USA facilities.

Energy Conservation:

Awarded an Energy Efficient Grant from the City of Monroe, North Carolina for two energy conservation initiatives:

Motion detectors installed on electrical switches throughout facility where practical.

More efficient T5 lights installed in manufacturing and warehouse areas.

Use of re-circulated and re-chilled water in mold production of plastic products and components.

Greiner Bio-One Green Initiatives