GEMS Win TTM & ICD GW-TTMICD

GUDID 00812324000228

GEMS Win ARR TTM & Full Pacing

CardioComm Solutions, Inc

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 Cardiac mapping system computer
Primary Device ID00812324000228
NIH Device Record Key0c7d12c9-ed65-4e8b-9e71-c93467313068
Commercial Distribution StatusIn Commercial Distribution
Brand NameGEMS Win TTM & ICD
Version Model NumberGW-TTMICD
Catalog NumberGW-TTMICD
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 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
GS100812324000228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSHRecorder, Magnetic Tape, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

Devices Manufactured by CardioComm Solutions, Inc

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 & ICD2023-11-16GEMS Win ARR TTM & Full Pacing
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
00812324000020 - HeartCheck BT PEN Handheld ECG2018-07-06 Bluetooth PEN Handheld ECG
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