FDA.reportPublic FDA data

GEMS Win TTM & ICD

Primary DI
00812324000228
Brand
GEMS Win TTM & ICD
Company
CardioComm Solutions, Inc
Model
GW-TTMICD
Catalog number
GW-TTMICD
Device description
GEMS Win ARR TTM & Full Pacing
Published
2023-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSHRecorder, Magnetic Tape, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSHRecorder, Magnetic Tape, MedicalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022297000GLOBAL ECG MANAGEMENT SYSTEM (GEMS)Cardiocomm Solutions, Inc.2002-09-27DSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812324000228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324000228008123240002288123240002280812324000228

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system computerA dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
251043907
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812324000136HeartCheck PalmHC-PM10HC-PM102017-11-30
00812324000297GEMS Mobile ECGGMGM2025-03-20
00812324000204GEMS Win ArrhythmiaGW-ARRGW-ARR2023-11-09
00812324000211GEMS Win TTMGW-TTMGW-TTM2023-11-09
00812324000242GEMS Win AutoAttendantGW-AAGW-AA2023-11-09
00812324000259GEMS Win AirGW-AIRGW-AIR2023-11-09
00812324000266GEMS Win HL7GW-HL7GW-HL72023-11-08
00812324000020HeartCheck BT PEN Handheld ECGHCEKGBTPEN30HCEKGBTPEN302017-11-28
00812324000044HeartCheck CardiBeatHC-WC-01HC-WC-012019-03-04

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