B1X5 Software Upgrade

GUDID 00840682141291

B125/B105 V1.5 SW PACK (USB) - MD

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

General-purpose multi-parameter bedside monitor
Primary Device ID00840682141291
NIH Device Record Keydd097498-4601-49da-a4c0-3adcd26e51e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameB1X5 Software Upgrade
Version Model NumberV1.5
Company DUNS784985108
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682141291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLWIndex-generating electroencephalograph software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-11-10
Device Publish Date2020-11-18

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