BD Vacutainer® Buff. Na Citrate 0.109M, 3.2%

Basic Information

• Brand Name: BD Vacutainer® Buff. Na Citrate 0.109M, 3.2%
• Primary DI: 50382903630801
• Version / Model: 363080
• Catalog Number: 363080
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 001292192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 4
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: f6289a64-a81f-4c50-8c95-c33ab81ba01b

Device Description

Tube CIT PLH 13x75 1.8 PLBL L/BL .109

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, vials, systems, serum separators, blood collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47592	Evacuated blood collection tube IVD, anticoagulant	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and an anticoagulant [e.g., sodium heparin, sodium citrate, potassium oxalate, ethylenediaminetetraacetic acid (EDTA)]. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood lead, toxicology, nutritional-chemistry, and other plasma chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50382903630801	GS1
Unit of Use	00382903630806	GS1
Package	30382903630807	GS1	Shelfpack	100	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K013971	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius