FDA.reportPublic FDA data

GEMS Win Air

Primary DI
00812324000259
Brand
GEMS Win Air
Company
CardioComm Solutions, Inc
Model
GW-AIR
Catalog number
GW-AIR
Device description
GEMS Win Air
Published
2023-11-09
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
00812324000259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812324000259008123240002598123240002590812324000259

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
00812324000228GEMS Win TTM & ICDGW-TTMICDGW-TTMICD2023-11-08
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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Primary DI, Brand, Company table
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04250413403578Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413403585Cuff ABPMpro without ECGSOMNOmedics AGDSH2026-07-07
04250413406456Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406463Cuff ABPMpro for right armSOMNOmedics AGDSH2026-07-07
04250413406470ABPMpro cuff for right armSOMNOmedics AGDSH2026-07-07
08883000003064AeviceMDAEVICE HEALTH PTE. LTD.DSH2026-06-22
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P00010eWave Electrode PatchWearlinq, Inc.DSH2026-04-02
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08800069700260AT-PatchATsens Co., Ltd.DSH2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DSH2025-11-05
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00884838127449Care AssistPhilips Medizin Systeme Böblingen GmbHDSH2025-05-06
27540279250029CardioSTATIcentia Inc.DSH2024-12-18
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00860007323409Vitals360Vocare, Inc.DSH2024-09-10