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

Detector And Alarm, Arrhythmia (DSI) (9) Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (1)

Premarket Exempt

Clear

Bracket - 90815187020030 Catalog Number : 106550

Device Description : ECG Mounting Accessory, ACM, WALL

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

Matrix Mini ECG Module Kit - 90815187020047 Catalog Number : 6000-ECG3I

Device Description : Module + USB + Patient Cable 3L IEC90815187020016; ECG Module90815187020078; Pa Module + USB + Patient Cable 3L IEC90815187020016; ECG Module90815187020078; Patient Cable 3L IEC90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Patient Cable - 90815187020054 Catalog Number : 6000-CBL3A

Device Description : Patient Cable 3L AHA

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Patient Cable - 90815187020061 Catalog Number : 6000-CBL5I

Device Description : Patient Cable 5L IEC

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Patient Cable - 90815187020078 Catalog Number : 6000-CBL3I

Device Description : Patient Cable 3L IEC

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Matrix Mini ECG Module Kit - 90815187020085 Catalog Number : 6000-ECG3A

Device Description : Module + USB + Patient Cable 3L AHA90815187020016; ECG Module90815187020054; Pa Module + USB + Patient Cable 3L AHA90815187020016; ECG Module90815187020054; Patient Cable 3L AHA90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Matrix Mini ECG Module Kit - 90815187020092 Catalog Number : 6000-ECG5I

Device Description : Module + USB + Patient Cable 5L IEC90815187020016; ECG Module90815187020061; Pa Module + USB + Patient Cable 5L IEC90815187020016; ECG Module90815187020061; Patient Cable 5L IEC90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

Matrix Mini ECG Module Kit - 90815187020108 Catalog Number : 6000-ECG5A

Device Description : Module + USB + Patient Cable 5L AHA90815187020016; ECG Module90815187020009; Pa Module + USB + Patient Cable 5L AHA90815187020016; ECG Module90815187020009; Patient Cable 5L AHA90815187020023; ECG Module USB Cable (18")90815187020030; ECG Mounting Accessory, ACM, WALL

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : Yes

Device Count : 1

USB Cable - 90815187020115 Catalog Number : 007-400-0145

Device Description : ECG Module USB Cable (3 meters)

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : DSI

Prescription Use : No

Device Count : 1

Patient Cable - 90815187020122 Catalog Number : 711059

Device Description : 5 Lead Patient Cable, IEC, HR300

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

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