Ortho Connect 2.0
by Biomedical Data Solutions Limited
Ortho Connect 2.0 is a Class II device made by Biomedical Data Solutions Limited, listed under FDA premarket submission BK160124 and listed in FDA GUDID since 2 Oct 2018 (UDI-DI 05060496770028), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
510(k) BK160124
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060496770028 | Date2 Oct 2018 | StatusListed |
| United States | FDA 510(k) | NumberBK160124 | Date— | StatusActive |
Official records
- AccessGUDID record 05060496770028
Across registries
- FDA premarket submission BK160124 Active
- FDA GUDID UDI-DI 05060496770028 listed 2 Oct 2018 Listed
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Ortho Connect
- Generic name
- Blood bank information system application software
- Model / reference
- 2.0
- Primary DI / UDI-DI
- 05060496770028
- FDA product code
- KSZ
- GMDN term
- Blood bank information system application software
- Device class
- Class II
- Regulation number
- 864.9175
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KSZ (System, Test, Automated Blood Grouping And Antibody).