Change Healthcare Cardiology ECG Management

GUDID 17540262110050

Change Healthcare Canada Company

Cardiac mapping system computer
Primary Device ID17540262110050
NIH Device Record Key74344e31-54d3-483c-9c85-0d989a1c617a
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Cardiology ECG Management
Version Model Number14.3.2
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
GS117540262110050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-05
Device Publish Date2021-01-28

On-Brand Devices [Change Healthcare Cardiology ECG Management]

1754026211004314.3
1754026211005014.3.2
1754026211009815.0
1754026211010415.0.1
1754026211003614.2
1754026211012815.1

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