Portrait CVAXB 5863721-11

GUDID 00195278656681

Portrait Central Viewer Application Installer v1.1.0

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only Wireless patient monitor/sensor reporting software, professional-only
Primary Device ID00195278656681
NIH Device Record Keyfcd4e8a1-e2cc-49a0-87ed-54e11025546a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortrait CVAXB
Version Model NumberCVAXB
Catalog Number5863721-11
Company DUNS006580799
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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
GS100195278656681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-08
Device Publish Date2024-04-30

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00195278656681 - Portrait CVAXB2024-05-08Portrait Central Viewer Application Installer v1.1.0
00195278656681 - Portrait CVAXB2024-05-08 Portrait Central Viewer Application Installer v1.1.0
00195278659446 - Portrait CSSXB2024-05-08 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
00195278789846 - Mural Clinical Viewer2024-03-21 MD Mural Clinical Viewer 1.2 MEDICAL DEVICE
00840682139250 - Portrait CAU012023-10-13 Portrait Clinical Alarming Unit CAU01
00195278330413 - Portrait CVA012023-09-11 PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
00195278341129 - Portrait CSS012023-09-11 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
00195278577559 - Mural Clinical Viewer2023-07-24 MD Mural Clinical Viewer MEDICAL DEVICE
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