Change Healthcare Enterprise Viewer

GUDID 17540262010022

Change Healthcare Canada Company

Radiology picture archiving and communication system application software
Primary Device ID17540262010022
NIH Device Record Key6cfbf833-b2f4-4cad-9bde-121976f92fbd
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Enterprise Viewer
Version Model Number2.0
Company DUNS246576391
Company NameChange Healthcare Canada Company
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
GS117540262010022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LLZSystem, Image Processing, Radiological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-05
Device Publish Date2019-03-28

On-Brand Devices [Change Healthcare Enterprise Viewer]

175402620100222.0
175402620100392.1
175402620100462.1.1
1754026201005314.2

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