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B125M Patient Monitor

by GE Medical Systems Information Technologies, Inc.

Ref 6160000-104, 6160000-004Model B105P, B105P B125P B105M B125M B155M

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

6 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number8406821BUG00323H7 Basic UDI-DI Date26 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278490247 UDI-DI Date12 Apr 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

6 recalls · 6 ongoing · FDA

    • Ongoing Z-0455-2026 FDA Class II initiated 26 Sep 2025

    Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.

  • 5 recalls, same reason

    • Ongoing Z-0730-2023 FDA Class II initiated 16 Nov 2022
    • Ongoing Z-0732-2023 FDA Class II initiated 16 Nov 2022
    • Ongoing Z-0731-2023 FDA Class II initiated 16 Nov 2022
    • Ongoing Z-0733-2023 FDA Class II initiated 16 Nov 2022
    • Ongoing Z-0729-2023 FDA Class II initiated 16 Nov 2022

    GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used in a location that is not at or near sea level.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
B125M Patient Monitor EUDAMED
B125M GUDID
Generic Name
General-purpose multi-parameter bedside monitor
Device Name
B105P Patient Monitor
B105P B125P B105M B125M B155M Patient Monitors
Model / Ref / Catalog
B105P, 6160000-104, B105P B125P B105M B125M B155M, 6160000-004, B125 VSP3.0 Patient Monitor, B125M Patient Monitor
Description
B125M ATO MODEL
B125M VSP4 ATO MODEL
Primary DI / UDI-DI
00195278490247, 00840682146715
Basic UDI-DI
8406821BUG00323H7, 8406821BUG00102GM
510(k) Number
FDA Product Code
OMC, CBQ, DPZ, DQK, MLD, GWQ, MHX, OLT, NHQ, DXN, CBS, DSI, CCL, KRB, NHO, DSK, OLW, BZQ, DQA, ORT, DRT, FLL, KOI, NHP, CBR, DSJ, CCK, GWO
EMDN Code
Z1203020201 Multi–parameter patient bedside monitors
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
882.1400, 868.1500, 870.2710, 870.1425, 870.1025, 870.1130, 868.1620, 868.1720, 870.1915, 870.1110, 868.2375, 870.2700, 870.2300, 880.2910, 868.2775, 868.1700, 870.1100, 868.1400, 882.5320
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
B105P
6160000-104
B105P B125P B105M B125M B155M
6160000-004
GUDID
B125 VSP3.0 Patient Monitor
B125M Patient Monitor
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000017529
Authorised representative
GE Medical Systems SCS FR-AR-000000344

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Properties

  • Measuring Function
  • Prescription Use NoGUDIDYesGUDID
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No