FDA.reportPublic FDA data

WA Holter System

Primary DI
90815187020290
Brand
WA Holter System
Company
GLOBAL INSTRUMENTATION, LLC
Model
HR300
Catalog number
404955
Device description
HR300 Mini Holter Recorder Repair Exchange
Published
2016-10-21
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
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
90815187020290PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9081518702029090815187020290

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
Serial number
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
90815187020719Matrix Holter System001-400-0123001-400-01232022-04-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
90815187020719Matrix 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