Pxp-1000 80101
Pxp-1000 80101 is a blood centrifugation system containment kit (FDA Class II; FDA product code OAO, Cord Blood Processing System And Storage Container) made by Thermogenesis Corp., listed under FDA premarket submission BK120061 and listed in FDA GUDID since 29 Sep 2021 (UDI-DI 00886368000100), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK120061
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00886368000100 | Date29 Sep 2021 | StatusListed |
| United States | FDA 510(k) | NumberBK120061 | Date— | StatusActive |
Official records
- AccessGUDID record 00886368000100
Across registries
- FDA premarket submission BK120061 Active
- FDA GUDID UDI-DI 00886368000100 listed 29 Sep 2021 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pxp-1000
- Generic name
- Blood centrifugation system containment kit
- Model / reference
- 80101
- Primary DI / UDI-DI
- 00886368000100
- FDA product code
- OAO
- GMDN term
- Blood centrifugation system containment kit
- Device class
- Class II
- Regulation number
- 864.9900
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Radiation Sterilization