CENTRICITY PERINATAL

GUDID 00195278454386

MD CPN 6.99 MEDICAL DEVICE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient health record information system
Primary Device ID00195278454386
NIH Device Record Keya7dc26ac-e91d-4c92-a48c-e749c5b2a534
Commercial Distribution StatusIn Commercial Distribution
Brand NameCENTRICITY PERINATAL
Version Model Number6.99
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278454386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, monitoring, perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-07
Device Publish Date2022-05-30

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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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

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