Portrait CSS01 5870857

GUDID 00195278341129

PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software Bedside information system application software
Primary Device ID00195278341129
NIH Device Record Key0fd149d2-0ddd-4595-8b55-43d2bcaabd51
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortrait CSS01
Version Model NumberCSS01
Catalog Number5870857
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
GS100195278341129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor, physiological, patient (without arrhythmia detection or alarms)

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.

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 CSS012023-09-11PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3
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
00195278571342 - ONE-CUF2023-05-24 ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, SINGLE
00195278571359 - ONE-CUF2023-05-24 ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE
00195278571366 - ONE-CUF2023-05-24 ONE-CUF, ADULT LONG, DINACLICK 5 , 23 - 33 CM, SINGLE
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