BD Vacutainer® K2 EDTA 10.8mg 368661

GUDID 50382903686617

BD Vacutainer® K2 EDTA 10.8mg

BECTON, DICKINSON AND COMPANY

Evacuated blood collection tube IVD, K2EDTA
Primary Device ID50382903686617
NIH Device Record Keyb3aaf9bc-4c11-4210-be0a-6fe2b0f7041c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Vacutainer® K2 EDTA 10.8mg
Version Model Number368661
Catalog Number368661
Company DUNS001292192
Company NameBECTON, DICKINSON AND COMPANY
Device Count1000
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903686612 [Unit of Use]
GS150382903686617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JKATubes, vials, systems, serum separators, blood collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-13

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382904449575 - BDXpert™ System2025-03-28 BDXpert™ System
00382904490829 - NMIC-3122025-03-28 NMIC-312
00382904490836 - NMIC/ID-3132025-03-28 NMIC/ID-313
00382906666482 - N/A2025-03-27 BD® CD26 (M-A261) APC
50382903041423 - N/A2025-03-25 NEEDLE 23GA 1-1/2IN BNS TW
30382903884378 - BD Insyte Vialon-E 20GA2025-03-25 INSYTE VIALON-E 20GA X 1.88IN
00382902411154 - BD Francisella tularensis Antigen2025-03-11 Vial Francisella Tularensis Antigen 5 Ml
00382902411161 - BD Francisella tularensis Antisera2025-03-11 Vial F Tularensis Antiserum

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.