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B1X5 Software Upgrade V1.5

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 Number00840682141291 UDI-DI Date18 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  • Withdrawn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

Trade Name
B1X5 Software Upgrade
Generic Name
General-purpose multi-parameter bedside monitor
Model / Reference
V1.5
Primary DI / UDI-DI
00840682141291
FDA Product Code
OLW, NHQ, OLT, DPZ, CBQ, CCL, DQA, MLD, DXN, OMC, CBR, MHX, CBS, CCK, DSJ, DQK, DSI, BZQ, ORT, DRT, FLL, KRB, NHO, GWQ, NHP, DSK
GMDN Term
General-purpose multi-parameter bedside monitor
Device Class
Class II
Regulation Number
882.1400, 868.1500, 870.2710, 868.1720, 870.2700, 870.1025, 870.1130, 868.1700, 868.1620, 868.1400, 870.1100, 870.1425, 868.2375, 870.2300, 880.2910, 870.1915, 870.1110
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe

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Properties

  • Prescription Use
  • Manufacturing Date

Other properties (12)

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