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Bis 186-0195-Ams

by Covidien LP

Bis 186-0195-Ams 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 10884521129832), 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

1 ongoing

This device is named in the recall

Documents

510(k) K072286

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 Number10884521129832 UDI-DI Date13 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK072286 Date20 Nov 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072286 decided 20 Nov 2007 Active
  • FDA GUDID UDI-DI 10884521129832 listed 13 Oct 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2958-2018 FDA Class II initiated 26 Jul 2018

    Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

Timeline

3 dated events

  1. Cleared FDA 510(k) K072286
  2. Listed FDA GUDID 10884521129832
  3. Recall initiated FDA recalls Z-2958-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bis
Generic name
Anaesthesia depth monitor
Model / reference
186-0195-AMS
Primary DI / UDI-DI
10884521129832
510(k) Number
FDA product code
OLW
GMDN term
Anaesthesia depth monitor
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Anaesthesia depth monitor

Cleared under the same submission (K072286)

and 8 more cleared under K072286

Similar devices

Other devices filed under FDA product code OLW (Index-generating electroencephalograph software).

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

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