Portrait CAU01 2102549-001

GUDID 00840682139250

Portrait Clinical Alarming Unit CAU01

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Physiologic monitoring system alarm
Primary Device ID00840682139250
NIH Device Record Key272e7577-3999-4092-9de2-c11df457a58b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortrait CAU01
Version Model NumberCAU01
Catalog Number2102549-001
Company DUNS006580799
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 Datefalse
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
GS100840682139250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-13
Device Publish Date2023-10-05

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