SUMMIT MEDICAL PRODUCTS, INC.

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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

Anesthesia Kit (OFQ) (10)

Premarket Exempt

No Yes

Clear

ambIT - 00857595005251 Catalog Number : 220343

Device Description : Pain Control System - Basic

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005268 Catalog Number : 220344

Device Description : Pain Control System - Standard

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005275 Catalog Number : 220449

Device Description : UMROI Pain Control System

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005282 Catalog Number : 220462

Device Description : Pain Control System - Basic with Filter Spike Cassette

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005305 Catalog Number : 220469

Device Description : St. Luke's Pain Control System

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005312 Catalog Number : 220470

Device Description : Pain Control System - Basic with Filter Male Luer Cassette + MediBag

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005329 Catalog Number : 220471

Device Description : Pain Control System - 5 inch Uni-Flo Fenestrated Catheter

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005336 Catalog Number : 220472

Device Description : Pain Control System - 10 inch Uni-Flo Fenestrated Catheter

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005343 Catalog Number : 220473

Device Description : Pain Control System - 3 inch Uni-Flo Fenestrated Catheter

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005350 Catalog Number : 220477

Device Description : RA PreSet Pain Control System

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

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