Identity
- Trade Name
- LT Kit for PRP FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Model / Reference
- PRP-B21 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974621793020 FDA UDI
- FDA Product Code
- GIO FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.6150 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
LT Kit for PRP by Zhuhai Longtime Biological Technology Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Zhuhai Longtime Biological Technology Co., Ltd
Sources (1)
- FDA UDI f3344509-d0f4-4799-a9b2-f8836d195b53 33 fields · synced Jun 1, 2026