MedGeneRx PRP HEALPRP15
MedGeneRx PRP HEALPRP15 is a haematological concentrate system (FDA Class II; FDA product code ORG, Platelet And Plasma Separator For Bone Graft Handling) made by Bimini Technologies LLC, listed under FDA premarket submission BK170136 and listed in FDA GUDID since 17 Feb 2022 (UDI-DI 00850034511597), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK170136
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00850034511597 | Date17 Feb 2022 | StatusListed |
| United States | FDA 510(k) | NumberBK170136 | Date— | StatusActive |
Official records
- AccessGUDID record 00850034511597
Across registries
- FDA premarket submission BK170136 Active
- FDA GUDID UDI-DI 00850034511597 listed 17 Feb 2022 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MedGeneRx PRP
- Generic name
- Haematological concentrate system
- Model / reference
- HEALPRP15
- Primary DI / UDI-DI
- 00850034511597
- FDA product code
- ORG
- GMDN term
- Haematological concentrate system
- Device class
- Class II
- Regulation number
- 864.9245
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code ORG (Platelet And Plasma Separator For Bone Graft Handling).