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

Electrocardiograph, Ambulatory, With Analysis Algorithm (MLO) (10)

Premarket Exempt

Clear

Patient Cable - 90815187020238 Catalog Number : 704548

Device Description : 7 Lead Patient Cable, IEC, HR100

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

GI Holter System - 90815187020245 Catalog Number : 004-400-0153

Device Description : M3R L Holter Recorder

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

GI Holter System - 90815187020252 Catalog Number : 001-400-0064

Device Description : M12R Holter Recorder

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

GI Holter System - 90815187020269 Catalog Number : 001-400-0122

Device Description : M12R L Holter Recorder

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

WA Holter System - 90815187020276 Catalog Number : 402810

Device Description : HR100 Holter Repair Exchange

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

WA Holter System - 90815187020283 Catalog Number : 402811

Device Description : HR300 Holter Repair Exchange

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

WA Holter System - 90815187020290 Catalog Number : 404955

Device Description : HR300 Mini Holter Recorder Repair Exchange

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : Yes

Device Count : 1

Pouch - 90815187020313 Catalog Number : 704553

Device Description : HR100 Carrying Case and Strap

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

Pouch - 90815187020320 Catalog Number : 704554

Device Description : HR300/HR1200/M3R/M12R Carrying Case and Strap

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

Battery Cover - 90815187020337 Catalog Number : 705674

Device Description : HR300/M3R/M12R Battery Cover

Device Class : 2

Duns Number: 147035427

Premarket Exempt : No

Product Code : MLO

Prescription Use : No

Device Count : 1

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