Portrait CVA01 5863721

GUDID 00195278330413

PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Wireless patient monitor/sensor reporting software, professional-only
Primary Device ID00195278330413
NIH Device Record Key723bdc41-ae9b-436d-a932-bc93dd90fc78
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortrait CVA01
Version Model NumberCVA01
Catalog Number5863721
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
GS100195278330413 [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 Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00195278421449 - CAM2025-04-15 CAM 14 - MDR
00195278421456 - CAM2025-04-15 CAM HD - MDR
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00195278617644 - CASE2025-04-02 CASE V7 GENERIC ATO
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