Change Healthcare Cardiology ECG Mobile

GUDID 17540262120028

CHANGE HEALTHCARE ISRAEL LTD

Cardiac mapping system computer
Primary Device ID17540262120028
NIH Device Record Keyf6d8e978-9b7b-4576-bf24-fe2df30ec968
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Cardiology ECG Mobile
Version Model Number1.3
Company DUNS600748180
Company NameCHANGE HEALTHCARE ISRAEL LTD
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
GS117540262120028 [Primary]

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 Date2019-04-23
Device Publish Date2019-04-15

On-Brand Devices [Change Healthcare Cardiology ECG Mobile]

175402621200111.2.4
175402621200281.3

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