BD Vacutainer® Trace Element K2 EDTA 10.8mg

Basic Information

• Brand Name: BD Vacutainer® Trace Element K2 EDTA 10.8mg
• Primary DI: 30382903683810
• Version / Model: 368381
• Catalog Number: 368381
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 001292192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 5
• Public Version Date: 2023-12-13
• Public Version Status: Update
• Public Device Record Key: 8dbd66ec-ea2a-4085-92fc-e187bc391f22

Device Description

TUBE TRCE PLH 13X100 6.0 UPLBL R/BL EDTA

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	30382903683810	GS1
Unit of Use	00382903683819	GS1
Package	50382903683814	GS1	Case	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K213953	000

Storage Conditions

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