Change Healthcare Cardiology ECG Management

GUDID 17540262110012

CHANGE HEALTHCARE ISRAEL LTD

Cardiac mapping system computer Cardiac mapping system computer
Primary Device ID17540262110012
NIH Device Record Key5b2bfe12-f7cd-4c6f-afe0-bf09a2aa6644
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Cardiology ECG Management
Version Model Number14.1
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
GS117540262110012 [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 Date2018-09-20
Device Publish Date2018-08-20

On-Brand Devices [Change Healthcare Cardiology ECG Management]

1754026211002914.1.1
1754026211001214.1

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