FDA.reportPublic FDA data

MAC

Primary DI
00195278840202
Brand
MAC
Company
Ge Medical Systems Information Technologies, Inc.
Model
7
Catalog number
22270007-021
Device description
MAC 7 15 Leads UPG KIT
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DHXSystem, Test, Carcinoembryonic Antigen
DPSElectrocardiograph
DQKComputer, Diagnostic, Programmable
DSACable, Transducer And Electrode, Patient, (Including Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DHXSystem, Test, Carcinoembryonic AntigenImmunology2
DPSElectrocardiographCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DSACable, Transducer And Electrode, Patient, (Including Connector)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251670000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251670000MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.2026-01-26DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278840202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278840202001952788402021952788402020195278840202

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Regulatory Flags#

DUNS number
118935631
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195278490742VSP4.058772592026-11-03
00840682117425NA2017842-0012016-07-08
00840682117531NA2023808-0022016-07-08
00840682117661NA2024565-0022016-07-08
00840682117678NA2024696-0012016-07-08
00840682118156N/A2017099-0032016-07-22
00840682118095N/A2017099-0012016-07-22
00840682119269NA3300782016-07-15
00840682119276NA3300882016-06-30
00840682104852NA2017098-0012016-07-22
00840682108928ApexProCH Transmitter2016-06-10
00840682109383CARESCAPET14 Transmitter2016-06-10
00840682116602NA2017008-0032016-07-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840416607451FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607468FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607475FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
00840416607482FOGG SYSTEM COMPANY, INC.Fogg System Company, Inc.DSA2026-11-02
06944413830585ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830592ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830608ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830615ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830622ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830639ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830646ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830653ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830660ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830677ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830684ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830691ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830707ECG CableEdan Instruments, Inc.DSA2026-11-02
06944413830714ECG CableEdan Instruments, Inc.DSA2026-11-02
G662ME550W1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028G1MaguireMaguire Enterprises, Inc.DSA2026-10-30
G662ME590028J1MaguireMaguire Enterprises, Inc.DSA2026-10-30
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-10-28
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DSA2026-10-28
04719872982296QT ECGQt Medical, Inc.DPS2026-10-28
04719872982302QT ECGQt Medical, Inc.DSA2026-10-28
04719872982302QT ECGQt Medical, Inc.DPS2026-10-28
04719872982418QT ECGQt Medical, Inc.DSA2026-10-28
08800159500060S-Patch CardioAIWellysis Corp.DPS2026-10-27
08800159500060S-Patch CardioAIWellysis Corp.DQK2026-10-27