Bis 186-0199-Rfb
by Covidien LP
Bis 186-0199-Rfb is a Class II device made by Covidien LP, cleared under FDA 510(k) K072286 on 20 Nov 2007 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 10884521129825), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521129825 | Date13 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK072286 | Date20 Nov 2007 | StatusActive |
Official records
- AccessGUDID record 10884521129825
- FDA 510(k) database K072286
Across registries
- FDA 510(k) K072286 decided 20 Nov 2007 Active
- FDA GUDID UDI-DI 10884521129825 listed 13 Oct 2016 Listed
Recalls
-
- Ongoing Z-2958-2018
Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems
Timeline
- Cleared FDA 510(k) K072286
- Listed FDA GUDID 10884521129825
- Recall initiated FDA recalls Z-2958-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bis
- Generic name
- Neurophysiologic monitoring system
- Model / reference
- 186-0199-RFB
- Primary DI / UDI-DI
- 10884521129825
- 510(k) Number
- FDA product code
- OLW
- GMDN term
- Neurophysiologic monitoring system
- Device class
- Class II
- Regulation number
- 882.1400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Neurophysiologic monitoring system.