GEMS Mobile ECG GM

GUDID 00812324000297

GEMS Mobile ECG software

CardioComm Solutions, Inc

Electrocardiograph, home-use
Primary Device ID00812324000297
NIH Device Record Key2076d575-f258-46d1-a9a2-b84fb04d37f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEMS Mobile ECG
Version Model NumberGM
Catalog NumberGM
Company DUNS251043907
Company NameCardioComm Solutions, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100812324000297 [Primary]

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

Devices Manufactured by CardioComm Solutions, Inc

00812324000297 - GEMS Mobile ECG2025-03-28GEMS Mobile ECG software
00812324000297 - GEMS Mobile ECG2025-03-28 GEMS Mobile ECG software
00812324000204 - GEMS Win Arrhythmia2023-11-17 Global ECG Management System (GEMS) for Windows Arrhythmia
00812324000211 - GEMS Win TTM2023-11-17 Global ECG Management System for Windows with Arrhythmia and TTM
00812324000242 - GEMS Win AutoAttendant2023-11-17 GEMS Win AutoAttendant
00812324000259 - GEMS Win Air2023-11-17 GEMS Win Air
00812324000228 - GEMS Win TTM & ICD2023-11-16 GEMS Win ARR TTM & Full Pacing
00812324000266 - GEMS Win HL72023-11-16 HL7 plug-in module for GEMS Win
00812324000044 - HeartCheck CardiBeat2019-03-12 HeartCheck CardiBeat portable ECG monitor

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