FDA.reportPublic FDA data

MAC

Primary DI
00840682144322
Brand
MAC
Company
GE Medical Systems Information Technologies, Inc.
Model
7
Catalog number
2109091-001
Device description
MAC 7
Published
2025-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQKComputer, Diagnostic, Programmable
DXHTransmitters And Receivers, Electrocardiograph, Telephone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203786000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203786000MAC 7 - Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.2021-04-30DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682144322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682144322008406821443228406821443220840682144322

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006580799
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278620873MAC72119091-0012026-03-31
00840682122504N/A420915-0692016-12-14
00840682122528N/A420915-0112016-12-13
00195278507037Mac-LabAltiX2300000-0032026-03-26
00195278507044CardioLabAltiX2300000-0042022-05-01
00195278507051ComboLabAltiX2300000-0052022-05-01
00195278507525MLCL Client SoftwareAltiX58896052022-05-01
00195278516015MLCL UpgradeAltiX58965972022-05-01
00195278330413Portrait CVA01CVA0158637212023-09-01
00195278341129Portrait CSS01CSS0158708572023-09-01
00840682104814NA2017098-0072016-07-22
00840682104845NA2017098-0032016-07-22
00840682104852NA2017098-0012016-07-22
00840682104869NA2017098-0052016-07-22
00840682109260CARESCAPETelemetry Server V42016-06-10
00840682104784N/APatient Data Module2016-05-27
00840682108775CARESCAPETelemetry Server v4 upgrade2016-06-10
00840682108799ApexPro600 MHz Receiver2016-06-10
00840682108928ApexProCH Transmitter2016-06-10
00840682109024ApexProFH Transceiver2016-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
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B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05