Blood Collection Kit

GUDID 00850037506170

The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag.

VERICEL CORPORATION

Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated Specimen container mailer, non-insulated
Primary Device ID00850037506170
NIH Device Record Key71681468-08ab-4c4e-870c-b1df152d91fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood Collection Kit
Version Model NumberN/A
Company DUNS079745570
Company NameVERICEL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850037506170 [Primary]

FDA Product Code

PQDBlood Specimen Collection Convenience Kit (Excludes Hiv)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-03
Device Publish Date2022-09-23

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00850037506170 - Blood Collection Kit2022-10-03The Blood Collection Kit is intended to provide a way to collect and transport venous blood samples to a biobanking facility. The Blood Collection Kit contains blood specimen collection devices and associated materials necessary to transport the samples to a biobanking facility. This includes two BD 10.0mL K2 EDTA (K2E) Plus Blood Collection Tubes (366643) and one VonSeal® 95kPA Biohazard Specimen Bag.
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00850037506095 - Sterilization Tray2022-07-25
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