Bis 186-0150
by Covidien LP
Bis 186-0150 is a Class II device made by Covidien LP, cleared under FDA 510(k) K143506 on 16 Apr 2015 (1 earlier submission) and listed in FDA GUDID since 17 Oct 2016 (UDI-DI 10884521134317), active as of 23 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 | Number10884521134317 | Date17 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143506 | Date16 Apr 2015 | StatusActive |
Official records
- AccessGUDID record 10884521134317
- FDA 510(k) database K143506
- FDA 510(k) database K093183
Across registries
- FDA 510(k) K143506 decided 16 Apr 2015 Active
- FDA GUDID UDI-DI 10884521134317 listed 17 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K093183
- Cleared FDA 510(k) K143506
- Listed FDA GUDID 10884521134317
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bis
- Generic name
- Cerebral oximeter sensor, single-use
- Model / reference
- 186-0150
- Primary DI / UDI-DI
- 10884521134317
- FDA product code
- GXY
- GMDN term
- Cerebral oximeter sensor, single-use
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe