FDA.reportPublic FDA data

Matrix Holter System

Primary DI
90815187020719
Brand
Matrix Holter System
Company
GLOBAL INSTRUMENTATION, LLC
Model
001-400-0123
Catalog number
001-400-0123
Device description
M12R L Recorder, 10-Lead Cable, AHA, System Kit90815187020184; M12R, 10 Lead patient Cable (DIN)90815187020252; M12R Holter Recorder90815187020320; M12R Carrying Case
Published
2022-04-29
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
MLOElectrocardiograph, Ambulatory, With Analysis Algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLOElectrocardiograph, Ambulatory, With Analysis AlgorithmCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051730000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051730000MATRIX HOLTER SYSTEM, MODEL M12Global Instrumentation, LLC2005-09-26MLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90815187020719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9081518702071990815187020719

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic ambulatory recorderAn electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147035427
Device count
1
Kit
true
Serial number
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815187020754M12 System000-400-0129000-400-01292024-12-03
00815187020112Matrix Wearable009-400-0206009-400-02062024-04-01
00815187020440Matrix Wearable009-400-0168009-400-01682024-04-01
00815187020457Matrix Wearable009-400-0169009-400-01692024-04-01
00815187020587Matrix Wearable009-400-0193009-400-01932024-04-01
00815187020594Matrix Wearable009-400-0194009-400-01942024-04-01
90815187020696Matrix Holter System001-400-0107001-400-01072022-04-29
90815187020702Matrix Holter System001-400-0105001-400-01052022-04-29
00815187020471Matrix Wearable009-400-0171009-400-01712021-03-11
00815187020549Matrix Wearable009-400-0178009-400-01782021-03-11
00815187020563Matrix Wearable009-400-0192009-400-01922021-03-11
00815187020600Matrix Wearable009-400-0195009-400-01952021-03-11
00815187020570Matrix Wearable009-400-0205009-400-02052021-08-10
00815187020433Matrix Wearable009-400-0167009-400-01672021-03-11
00815187020556Matrix WearableM5009-400-01802021-03-11
90815187020122Patient Cable001-400-00957110592016-10-21
90815187020139Patient Cable001-400-00177045492016-10-21
90815187020146Patient Cable001-400-00287045502016-10-21
90815187020153Patient Cable001-400-0018001-400-00182016-10-21
90815187020160Patient Cable001-400-0004001-400-00042016-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069700109AT-ReportATsens Co., Ltd.MLO2025-11-05
08800069700260AT-PatchATsens Co., Ltd.MLO2025-11-05
08800069700277AT-PatchATsens Co., Ltd.MLO2025-11-05
00817111021332PolysmithNeurotronics, LLCMLO2025-09-23
08908013617128Frontier X PlusFOURTH FRONTIER TECHNOLOGIES PRIVATE LIMITEDMLO2025-02-07
00732094356861Welch Allyn, Inc.WELCH ALLYN, INC.MLO2024-12-18
00732094356878Welch Allyn, Inc.WELCH ALLYN, INC.MLO2024-12-18
00815187020754M12 SystemGLOBAL INSTRUMENTATION, LLCMLO2024-12-03
00862887000319TelePatch Cardiac MonitorMEDICOMP, INC.MLO2024-07-24
B632MDB01042MedibluMEDIBLU MEDICAL LLCMLO2023-11-17
00862887000388TelePatch Cardiac MonitorMEDICOMP, INC.MLO2023-09-25
00732094327496Welch Allyn, Inc.WELCH ALLYN, INC.MLO2023-09-15
00817111021257Polysmith Version 12.2Neurotronics, LLCMLO2022-12-28
90815187020696Matrix Holter SystemGLOBAL INSTRUMENTATION, LLCMLO2022-04-29
90815187020702Matrix Holter SystemGLOBAL INSTRUMENTATION, LLCMLO2022-04-29
00732094350753Welch Allyn, Inc.WELCH ALLYN, INC.MLO2021-09-27
00732094345643Welch Allyn, Inc.WELCH ALLYN, INC.MLO2021-02-10
00841709118067MIDMARK IQHOLTER® PLUG-IN SOFTWAREMIDMARK CORPORATIONMLO2020-12-28
00732094338812Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-09-14
00884838094895Holter SoftwarePhilips Medical Systems HsgMLO2020-08-19
00860000272407Rhythm ExpressVIVAQUANT, INC.MLO2020-07-27
B146ER9WCNC0ER9W CDMA wEventBRAEMAR MANUFACTURING, LLCMLO2020-07-15
B146ERWCD020ER9W CDMA First Call MedBRAEMAR MANUFACTURING, LLCMLO2020-07-15
B146ERWCD030ER9W CDMA UNMBRAEMAR MANUFACTURING, LLCMLO2020-07-15
00817111021172Polysmith Version 12.0Neurotronics, LLCMLO2020-04-01
00732094263978Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-03-24
00732094281330Welch Allyn, Inc.WELCH ALLYN, INC.MLO2020-03-24
00732094261301Welch Allyn, Inc.WELCH ALLYN, INC.MLO2019-12-04
00732094325607Welch Allyn, Inc.WELCH ALLYN, INC.MLO2019-10-10
B146C2MA000Millennia SoftwareBRAEMAR MANUFACTURING, LLCMLO2019-10-10