Bci 1163
Bci 1163 is a general-purpose multi-parameter bedside monitor (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by ICU Medical, Inc., cleared under FDA 510(k) K991086 on 9 Jun 1999 and listed in FDA GUDID since 13 Oct 2016 (UDI-DI 35019517053665), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number35019517053665 | Date13 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK991086 | Date9 Jun 1999 | StatusActive |
Official records
- AccessGUDID record 35019517053665
- FDA 510(k) database K991086
Across registries
- FDA 510(k) K991086 decided 9 Jun 1999 Active
- FDA GUDID UDI-DI 35019517053665 listed 13 Oct 2016 Listed
Recalls
-
- Terminated Z-0920-2010
Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are eq
Timeline
- Cleared FDA 510(k) K991086
- Recall initiated FDA recalls Z-0920-2010
- Listed FDA GUDID 35019517053665
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Bci
- Generic name
- General-purpose multi-parameter bedside monitor
- Model / reference
- 1163
- Primary DI / UDI-DI
- 35019517053665
- 510(k) Number
- FDA product code
- CCK
- GMDN term
- General-purpose multi-parameter bedside monitor
- Device class
- Class II
- Regulation number
- 868.1400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under General-purpose multi-parameter bedside monitor.
- LiDCO Ltd Li11143 by LIDCO LIMITED
- Welch Allyn, Inc. 901060 68NXTP by Welch Allyn, Inc.
- Root™ with noninvasive blood pressure and temperature 9695 by MASIMO CORPORATION
- Pedi-lite+ Spirometry Kit, pediatric, 3m/10ft M1032634 by GE Healthcare Finland Oy
- Patient Spirometry Tubes 884101 by GE Healthcare Finland Oy
- Welch Allyn, Inc. 901060 67NCDX by Welch Allyn, Inc.
- LiDCO Ltd Li10739 by LIDCO LIMITED
- HemoSphere Vita HEMPC2K by Edwards Lifesciences LLC
- Patient Monitor CX12 by Edan Instruments, Inc.
- Vital Signs Monitor M3B by Edan Instruments, Inc.