1. BD Life Sciences, Preanalytical Systems
BD.com
TECHNICAL INFORMATION SHEET
BD Vacutainer®
Sodium Fluoride and Sodium Heparin Tube
with BD Hemogard
Product Catalogue Number: 367764
Intended Use
Single use, evacuated, sterile blood collection tubes containing Sodium Fluoride and Sodium Heparin intended for the primary
containment and preservation of specimens for the purposes of in-vitro diagnostic examination. Used to obtain a plasma sample, in
which the glycolysis process is inhibited. These products are intended for use by healthcare professionals.
Manufacturing Information
(Legal) Manufacturer: Becton, Dickinson and Company Belliver Industrial
Estate Belliver Way Roborough, Plymouth, PL6 7BP,
UK.
Standards & Certificate
Numbers:
ISO 14001, EMS37154 ISO 13485, FM79169
Country of origin: UK
Certification body: BSI
Sterilisation
Method: Gamma Irradiation, Co-60
SAL: 10-6
Standards applied: EN ISO 11137
Relevant Product Standards & Guidelines
Standards: EN14820
Guidelines: Clinical and Laboratory Standards Institute
(CLSI; Formerly NCCLS): Tubes and Additives
for Venous Blood Specimen Collection;
Approved Guideline (6th Edition). Document
GP-A6. Wayne, PA, USA, 2010.Compliance
Directive: European In Vitro Diagnostic Medical Devices Directive
98/79/EC
Classification: Non Annex II / General IVD
Product Specification
Tube material: Glass
Tube size (mm): 13 x 75
Draw volume (mL): 5
Additives: Sodium Fluoride (4mg/mL), Sodium Heparin
(28IU/mL)
Closure material (cap): Polymer (low density Polyethylene resin)
Closure material (stopper): Bromobutyl Elastomer
Closure colour: Grey
Product Storage: Do not expose to direct sunlight
Store product between 4° and 25°C
Label type: Paper
Shelf-life: 18 months
Global medical device nomenclature (GMDN): 42836
Material Safety Data Sheet (MSDS): VS8020027
Fill line indicator: No
Latex (NRL): No
Dry Natural Rubber (DNR): No
Phthalates: No
Material of animal origin: Sodium Heparin: Porcine Origin
Packaging Specifications
100 unit pack weight (kg): 0.82 100 unit packaging material: Expanded Polystyrene (EPS) /
Polyolefin film
100 unit pack volume (m3): 0.002380 100 unit packaging weight (kg): 0.02
100 unit pack dimensions LxHxW (mm): 180 x 87 x 152 100 unit packaging volume (m3): 0.000680
1000 unit pack weight (kg): 8.54 1000 unit packaging material: Cardboard
1000 unit pack volume (m3): 0.023660 1000 unit packaging weight (kg): 0.298
1000 unit pack dimensions LxHxW (mm): 430 x 304 x 181 1000 unit packaging volume (m3): 0.024645
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TIS367764, CF, 23 05 14, 01

2. BD Vacutainer®
Sodium Fluoride and Sodium Heparin Tube with
BD Hemogard Product Catalogue Number: 367764
Labelling Information
All labelling complies with the requirements of the European Medical Devices Directive 93/42/EEC and includes CE marking.
Unit Pack Shelf Pack Case Pack
Company name • • •
Manufacturer address • • •
Product Catalogue Number (PCN) • • •
Sterile symbol showing method of sterilisation • • •
Colour Coding • • •
CE marking • • •
Single use symbols • • •
Lot number • • •
Instructions for Use (pictorials) •
Cannula dimensions • • •
Storage instructions • •
Quantity in package • •
Primary barcode (GS1-128) product identification • •
Secondary barcode (GS1-128) qty, expiry, lot number •
Product name & short description • • •
EU Authorised Representative
Instructions For Use
Sample Storage & Stability
Storage & Stability: When plasma is in contact with the cells after
centrifugation:
? 24h: store sample at 25°C
? 48h: store samples at 2 - 8°C
Stability depends on the analyte (see specific analyte).
References
1. Clinical and Laboratory Standards Institute (CLSI; formerly NCCLS): Procedures for
the Handling and Processing of Blood Specimens; Approved Guideline (4th
Edition). Document H18-A4. Wayne, PA, USA: 2010.
2. Guder WG, et al. Recommendations of the Working Group on Preanalytical Quality
of the German Society for Clinical Chemistry and Laboratory Medicine for Quality
of Diagnostic Samples (3rd Edition). Darmstadt, Germany: GIT, 2010.
3. Tietz NW. Clinical Guide to Laboratory Tests (4th Edition). W.B. Saunders, USA:
2006.
Further Reading
1. Guder WG, Narayanan S, Wisser H and Zawta B. Samples: From the Patient to the
Laboratory: the Impact of Preanalytical Variables on the Quality of Laboratory
Results (4th Edition). Darmstadt, Germany: Wiley-VCH; 2009.
2. Scheidhauer R, Guessregen B, Hohl A, Arndt T. "Effects of Prolonged Ambient
Storage of Sodium Fluoride/Heparin Specimens on Plasma Homocysteine". Clin
Chem. 2005; 51(8): 1564-65.
3. Evans MJ, Livesey JH, Ellis MJ and Yandle TG. "Effect of Anticoagulants and Storage
Temperatures on Stability of Plasma and Serum Hormones". Clin Biochem. 2001;
34: 107-112.
4. Chan AY, Swaminathan R and Cockram CS. "Effectiveness of Sodium Fluoride as a
Preservative of Glucose in Blood". Clin Chem. Feb 1989; 35: 315 – 317.
5. Uchida K, Matuse R, Toyoda E, Okuda S and Tomita S. "A New Method of Inhibiting
Glycolysis in Blood Samples". Clinica Chimica Acta. Feb. 1988; 172(1): 101-8.
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