Skip to content

NA B105 Patient Monitor

by GE Medical Systems Information Technologies, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682138574 UDI-DI Date16 Nov 2020ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
General-purpose multi-parameter bedside monitor
Model / Ref / Catalog
B105 Patient Monitor, 2099000-003
Primary DI / UDI-DI
00840682138574
FDA Product Code
FLL, CCK, CBS, KRB, NHQ, CCL, MLD, DQA, NHO, DRT, DSK, NHP, DPZ, BZQ, DSJ, DQK, DSI, CBQ, OLW, GWQ, MHX, CBR, OMC, ORT, OLT, DXN
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class II
Regulation Number
880.2910, 868.1400, 868.1620, 870.1915, 868.1500, 868.1720, 870.1025, 870.2700, 870.2300, 870.1110, 870.2710, 868.2375, 870.1100, 870.1425, 882.1400, 868.1700, 870.1130
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

Other devices from GE Medical Systems Information Technologies, Inc.

See all devices from GE Medical Systems Information Technologies, Inc. →

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No