Identity
- Trade Name
- Accelerate II Platelet Concentrating System 60mL FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, bone marrow concentration FDA UDI
- Model / Reference
- 620-12-02 FDA UDI
Identifiers
- Catalog Number
- 620-12-02 FDA UDI
- Primary DI / UDI-DI
- 00855306003381 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, bone marrow concentration FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentrationHaematological concentrate system preparation kit, bone marrow concentration
Accelerate II Platelet Concentrating System 60mL by EmCyte Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK050055 also covers:
- AbsolutePRP 120mL GenesisCS Component Concentrating System — EmCyte Corporation
- AbsolutePRP 30mL GenesisCS Component Concentrating System — EmCyte Corporation
- AbsolutePRP 60mL GenesisCS Component Concentrating System — EmCyte Corporation
- AcCELLerated Biologics PURE PRP II 60mL GenesisCS Component Concentrating System — EmCyte Corporation
- Accelerate II Platelet Concentrating System PRP-S 30mL — EmCyte Corporation
- Accelerate II Platelet Concentrating System PRP-S 30mL — EmCyte Corporation
- Accelerate II Platelet Concentrating System PRP-S 60mL — EmCyte Corporation
- Accelerate II Platelet Concentrating System PRP-S 60mL — EmCyte Corporation
- Accelerate PRP-G 60mL GenesisCS Component Concentrating System — EmCyte Corporation
- Accelerate Platelet Concentrating System 60mL — EmCyte Corporation
- Accelerate Platelet Concentrating System PRP-S 30mL — EmCyte Corporation
- Accelerate Platelet Concentrating System PRP-S 30mL — EmCyte Corporation
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 I | Pending data |
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Manufacturer
- Manufacturer
- EmCyte Corporation
Sources (1)
- FDA UDI 79b46e69-86bf-4b61-81cd-c1707065b760 36 fields · synced Jun 9, 2026