Identity
- Trade Name
- Blood Collection Kit FDA UDI
- Generic Name
- Specimen container mailer, non-insulated FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850037506170 FDA UDI
- FDA Product Code
- PQD FDA UDI
- GMDN Term
- Specimen container mailer, non-insulated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Specimen container mailer, non-insulatedEvacuated blood collection tube IVD, anticoagulant
Blood Collection Kit by Vericel Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated blood collection tube IVD, anticoagulant.
- BD Vacutainer® Buffered Sodium Citrate 0.3mL - 0.109M — Becton, Dickinson U.K. Limited · Class II
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- Vacuette — Greiner Bio-One GmbH · Class II
- BD Vacutainer® K2 EDTA (K2E) 3.6mg Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
- BD Vacutainer® Sodium HeparinN (NH) 158 U.S.P. Units Blood Collection Tubes — BECTON DICKINSON AND COMPANY · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vericel Corporation
Sources (1)
- FDA UDI 71681468-08ab-4c4e-870c-b1df152d91fc 33 fields · synced May 29, 2026