GLOBAL INSTRUMENTATION, LLC

Address:7010 Fly Road STE 5,E Syracuse,NY,13057,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Recorder, Magnetic Tape, Medical (DSH) (7) Detector And Alarm, Arrhythmia (DSI) (3)

Premarket Exempt

Clear

Matrix Wearable - 00815187020433 Catalog Number : 009-400-0167

Device Description : M5 Patch Electrode, 2-Lead

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Matrix Wearable - 00815187020471 Catalog Number : 009-400-0171

Device Description : M5 4-Lead Patient Cable - RL Lead AHA

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Matrix Wearable - 00815187020549 Catalog Number : 009-400-0178

Device Description : M5 USB Cable 1-Meter

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Matrix Wearable - 00815187020556 Catalog Number : 009-400-0180

Device Description : M5 Recorder

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Matrix Wearable - 00815187020563 Catalog Number : 009-400-0192

Device Description : M5 Recorder, USB Cable, USB Wall Charger, System Kit00815187020556; M5 Recorder0 M5 Recorder, USB Cable, USB Wall Charger, System Kit00815187020556; M5 Recorder00815187020549; M5 USB Cable 1-Meter

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Matrix Wearable - 00815187020570 Catalog Number : 009-400-0205

Device Description : M5 Neck Lanyard

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Matrix Wearable - 00815187020600 Catalog Number : 009-400-0195

Device Description : M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit00815187020556; M5 Reco M5 Recorder, 4-Lead Patient Cable RL Lead AHA, System Kit00815187020556; M5 Recorder00815187020471; M5 4-Lead Patient Cable - RL Lead AHA00815187020549; M5 USB Cable 1-Meter

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSH

Prescription Use : Yes

Device Count : 1

Patient Cable - 90815187020009 Catalog Number : 6000-CBL5A

Device Description : Patient Cable 5L AHA

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Matrix Mini - 90815187020016 Catalog Number : 6000-ECG

Device Description : ECG Module

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

USB Cable - 90815187020023 Catalog Number : 106512

Device Description : ECG Module USB Cable (18")

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

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