FDA.reportPublic FDA data

MAC

Primary DI
00840682123112
Brand
MAC
Company
GE Medical Systems Information Technologies, Inc.
Model
5500 HD REMAN
Device description
MAC 5500 HD REMAN
Published
2017-04-11
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
K110266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110266000MAC 5500 HD, MAC 3500Ge Medical Systems Information Technologies, Inc.2011-04-29DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682123112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682123112008406821231128406821231120840682123112

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiograph, professional, multichannelA device intended to be used by a healthcare professional in a clinical setting to record the electrical activity of the heart and display it in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed to record the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel). It may be intended for use while the patient is at rest (rest ECG) and/or during physical exercise (stress/exercise ECG), and may include a variety of additional features [e.g., interpretive software, data telemetry, display screen]; electrodes may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQK2026-10-04
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
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
00810209880118CORE 500 Digital Stethoscope - Lilac ChestpieceEko Health, Inc.DPS2026-10-01
00810209880163CORE 500 Digital Stethoscope FIGS Earpiece - EspressoEko Health, Inc.DPS2026-10-01
00810209880170CORE 500 Digital Stethoscope FIGS Earpiece - Ruby RedEko Health, Inc.DPS2026-10-01
00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
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00199150062911N/AMEDTRONIC, INC.DQK2026-09-04
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00198953213094Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-08-26
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