Identity
- Trade Name
- BioCUE® FDA UDI
- Generic Name
- Haematological concentrate system FDA UDI
- Model / Reference
- 800-0614 FDA UDI
Identifiers
- Catalog Number
- 800-0614 FDA UDI
- Primary DI / UDI-DI
- 00880304640917 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Haematological concentrate system 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
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
BioCUE® by Biomet Biologics, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
BK100027 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Biologics, LLC
Sources (1)
- FDA UDI 012c92c2-3d95-444c-b181-d25683027ca2 36 fields · synced Jun 8, 2026