Acp 215 02215-110-E
Acp 215 02215-110-E is a Class II device made by Haemonetics Corporation, listed under FDA premarket submission BK030062 (2 earlier submissions) and listed in FDA GUDID since 31 Jan 2017 (UDI-DI 30812747015800), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK030062
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30812747015800 | Date31 Jan 2017 | StatusListed |
| United States | FDA 510(k) | NumberBK030062 | Date— | StatusActive |
Official records
- AccessGUDID record 30812747015800
Across registries
- FDA premarket submission BK030062 Active
- FDA GUDID UDI-DI 30812747015800 listed 31 Jan 2017 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acp 215
- Generic name
- Blood cell freeze/thaw system
- Model / reference
- 02215-110-E
- Primary DI / UDI-DI
- 30812747015800
- FDA product code
- KSW
- GMDN term
- Blood cell freeze/thaw system
- Device class
- Class II
- Regulation number
- 864.9145
- GUDID distribution status
- In Commercial Distribution