Identity
- Trade Name
- 3C Patch® Device FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- Holds the blood at collection and during processing in the centrifuge. FDA UDI
- Model / Reference
- 2 FDA UDI
- Description
- Holds the blood at collection and during processing in the centrifuge. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714188502106 FDA UDI
- FDA Product Code
- PMQ FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
3C Patch® Device by Reapplix ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- RegenKit-BCT-3 (20ml)/RegenPlasma — REGEN LAB SA · Class II
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- Precise Sapphire — Arteriocyte Medical Systems, Inc. · Class II
Cleared under the same submission
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
- Reapplix ApS
Sources (1)
- FDA UDI a4b5d1ee-e50c-4098-b71a-9392970db122 35 fields · synced May 30, 2026