Identity
- Trade Name
- Plasmax® Plus Plasma Concentration Kit FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Model / Reference
- 800-0517 FDA UDI
Identifiers
- Catalog Number
- 800-0517 FDA UDI
- Primary DI / UDI-DI
- 00880304681446 FDA UDI
- FDA Product Code
- KSS FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.9050 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
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
No
FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
Plasmax® Plus Plasma Concentration Kit 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
BK070026 also covers:
- GPS® III — Biomet Biologics, LLC
- GPS® III — Biomet Biologics, LLC
- GPS® III PLATELET CONCENTRATION SYSTEM — Biomet Biologics, LLC
- GPS® III PLATELET CONCENTRATION SYSTEM — Biomet Biologics, LLC
- GPS® III Platelet Concentration System — Biomet Biologics, LLC
- GPS® III Platelet Concentration System — Biomet Biologics, LLC
- GPS®III Mini Platelet Concentration System — Biomet Biologics, LLC
- Plasmax® Plasma Concentration Kit — Biomet Biologics, LLC
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
- Biomet Biologics, LLC
Sources (1)
- FDA UDI ff2f5b77-fdaa-4403-944d-efdfc4d77947 35 fields · synced May 30, 2026