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
00840682105491SOFT-CUFSFT-F1-2E2016-06-30
00840682106818SOFT-CUF21262016-06-30
00840682107150SOFT-CUF2362-INT2362-INT2016-06-30
00840682108805CLASSIC-CUF23592016-06-30
00840682108874CLASSIC-CUF23582016-06-30
00840682109215CLASSIC-CUF21382016-06-30
00840682109291CLASSIC-CUF21332016-06-30
00840682109307CLASSIC-CUF21192016-06-30
00840682109437CLASSIC-CUF230723072016-06-30
00840682109635CLASSIC-CUF230223022016-06-30
00840682109710CLASSIC-CUF230523052016-06-30
00840682110778SENSA-CUF24702016-06-30
00840682110792SENSA-CUF24622016-06-30
00840682110822SENSA-CUF24642016-06-30
00840682110839SENSA-CUF24682016-06-30
00840682110846SENSA-CUF24742016-06-30
00840682110907SENSA-CUF24722016-06-30
00840682110914SENSA-CUF24662016-06-30
00840682110969SENSA-CUF24782016-06-30
00840682111270SENSA-CUF24762016-06-30

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Primary DI, Brand, Company table
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00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
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00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
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00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
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00198953243626MLCL Client SoftwareGe Medical Systems Information Technologies, Inc.DQK2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DPS2026-08-26
05415067055651EnSite™ST. JUDE MEDICAL, INC.DQK2026-08-19