Change Healthcare Cardiology ECG Mobile

GUDID 17540262120011

CHANGE HEALTHCARE ISRAEL LTD

Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer
Primary Device ID17540262120011
NIH Device Record Key1a9e85db-f4fb-47f1-8aac-fc8798a73e3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameChange Healthcare Cardiology ECG Mobile
Version Model Number1.2.4
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
GS117540262120011 [Primary]

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-08-15
Device Publish Date2018-05-20

On-Brand Devices [Change Healthcare Cardiology ECG Mobile]

175402621200111.2.4
175402621200281.3

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.