BloodSafe 4.x.x
BloodSafe 4.x.x is a Class II device made by Haemonetics Corporation, listed under FDA premarket submission BK140133 and listed in FDA GUDID since 15 Dec 2016 (UDI-DI 00812747010019), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK140133
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00812747010019 | Date15 Dec 2016 | StatusListed |
| United States | FDA 510(k) | NumberBK140133 | Date— | StatusActive |
Official records
- AccessGUDID record 00812747010019
Across registries
- FDA premarket submission BK140133 Active
- FDA GUDID UDI-DI 00812747010019 listed 15 Dec 2016 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- BloodSafe
- Generic name
- Clinical laboratory information system application software
- Model / reference
- 4.x.x
- Primary DI / UDI-DI
- 00812747010019
- FDA product code
- MMH
- GMDN term
- Clinical laboratory information system application software
- Device class
- Class II
- Regulation number
- 864.9165
- GUDID distribution status
- In Commercial Distribution