FDA.reportPublic FDA data

Matrix Mini ECG Module Kit

Primary DI
90815187020047
Brand
Matrix Mini ECG Module Kit
Company
GLOBAL INSTRUMENTATION, LLC
Model
6000-ECG3I
Catalog number
6000-ECG3I
Device description
"Module + USB + Patient Cable 3L IEC90815187020016; ECG Module90815187020078; Patient Cable 3L IEC90815187020023; ECG Module USB Cable (18"")90815187020030; ECG Mounting Accessory, ACM, WALL"
Published
2017-09-29
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
DSIDetector And Alarm, Arrhythmia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
90815187020047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9081518702004790815187020047

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic monitorA mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147035427
Device count
1
Combination product
true
Lot or batch
true
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

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