Bci 9004000
Bci 9004000 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K970209 on 18 Apr 1997 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 10610586036811), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10610586036811 | Date13 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK970209 | Date18 Apr 1997 | StatusActive |
Official records
- AccessGUDID record 10610586036811
- FDA 510(k) database K970209
Across registries
- FDA 510(k) K970209 decided 18 Apr 1997 Active
- FDA GUDID UDI-DI 10610586036811 listed 13 Oct 2016 Listed
Recalls
-
- Terminated Z-1014-2013
In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.
Timeline
- Cleared FDA 510(k) K970209
- Recall initiated FDA recalls Z-1014-2013
- Listed FDA GUDID 10610586036811
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bci
- Generic name
- Carbon dioxide monitor
- Model / reference
- 9004000
- Primary DI / UDI-DI
- 10610586036811
- 510(k) Number
- FDA product code
- CCK
- GMDN term
- Carbon dioxide monitor
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- In Commercial Distribution
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