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Bci 9004007

by ICU Medical, Inc.

Bci 9004007 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 10610586036859), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K970209

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10610586036859 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970209 Date18 Apr 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970209 decided 18 Apr 1997 Active
  • FDA GUDID UDI-DI 10610586036859 listed 13 Oct 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1014-2013 FDA Class I initiated 6 Feb 2013

    In rare instances, the BCI Remote Alarm Cables (BCI Cable) are not transferring alarms when used with some remote nurse alarm systems.

Timeline

3 dated events

  1. Cleared FDA 510(k) K970209
  2. Recall initiated FDA recalls Z-1014-2013
  3. Listed FDA GUDID 10610586036859

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bci
Generic name
Carbon dioxide monitor
Model / reference
9004007
Primary DI / UDI-DI
10610586036859
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

Related devices

Category: Carbon dioxide monitor

Cleared under the same submission (K970209)

and 8 more cleared under K970209

Similar devices

Other devices filed under FDA product code CCK (ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE).

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)