Change Healthcare Cardiology

GUDID 17540262090116

Change Healthcare Canada Company

Cardiology information system
Primary Device ID17540262090116
NIH Device Record Keyc9d2848f-6c3e-4741-928c-de6090b8fff6
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Cardiology
Version Model Number15.0.1
Company DUNS246576391
Company NameChange Healthcare Canada Company
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS117540262090116 [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 Date2022-07-22
Device Publish Date2022-07-14

On-Brand Devices [Change Healthcare Cardiology]

1754026209004814.3
1754026209005514.3.2
1754026209010915.0
1754026209011615.0.1
1754026209003114.2
1754026209013015.1

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