GUDID 00840682115773

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Smoke/fire alarm system
Primary Device ID00840682115773
NIH Device Record Keyacd7850d-e51c-46e2-a4f0-2418dc4bf0fe
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRemote Alarm Box
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-5120
Emailxx@xx.xx

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100840682115773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDETECTOR AND ALARM, ARRHYTHMIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-22

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00840682144322 - MAC2025-03-21 MAC 7
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00195278990945 - Mural Clinical Viewer2025-02-28 MD Mural Clinical Viewer 1.3 MEDICAL DEVICE
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00195278561312 - Portrait VSM2024-05-13 Portrait VSM ATO MODEL

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