Portrait CSSXB 5933539

GUDID 00195278659446

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Bedside information system application software
Primary Device ID00195278659446
NIH Device Record Key21a2a058-8bc2-4bb8-bfaf-87db87238b18
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortrait CSSXB
Version Model NumberCSSXB
Catalog Number5933539
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
GS100195278659446 [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

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00195278421449 - CAM2025-04-15 CAM 14 - MDR
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