Unimed G-BIS-SEN4A
by Unimed Medical Supplies, Inc.
Unimed G-BIS-SEN4A is a Class II device made by Unimed Medical Supplies, Inc., cleared under FDA 510(k) K152472 on 31 Oct 2016 and listed in FDA GUDID since 29 May 2023 (UDI-DI 06936735487714), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06936735487714 | Date29 May 2023 | StatusListed |
| United States | FDA 510(k) | NumberK152472 | Date31 Oct 2016 | StatusActive |
Official records
- AccessGUDID record 06936735487714
- FDA 510(k) database K152472
Across registries
- FDA 510(k) K152472 decided 31 Oct 2016 Active
- FDA GUDID UDI-DI 06936735487714 listed 29 May 2023 Listed
Timeline
- Cleared FDA 510(k) K152472
- Listed FDA GUDID 06936735487714
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Unimed
- Generic name
- Invasive-pressure external transducer, single-use
- Model / reference
- G-BIS-SEN4A
- Primary DI / UDI-DI
- 06936735487714
- 510(k) Number
- FDA product code
- DRS
- GMDN term
- Invasive-pressure external transducer, single-use
- Device class
- Class II
- Regulation number
- 870.2850
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Invasive-pressure external transducer, single-use.