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

Pump, Infusion (FRN) (7) Blade, Scalpel (GES) (2) Pump, Infusion, Pca (MEA) (1)

Premarket Exempt

No Yes

Clear

Uni-Flo - 00857595005411 Catalog Number : 220489

Device Description : Uni-Flo™ Fenestrated Catheter – 2.5 inch (63.5 mm), 19 GA x 36 in (914mm)

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Uni-Flo - 00857595005428 Catalog Number : 220490

Device Description : Uni-Flo™ Fenestrated Catheter – 5 inch (127mm), 19 GA x 36 in (914mm)

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Uni-Flo - 00857595005435 Catalog Number : 220491

Device Description : Uni-Flo™ Fenestrated Catheter – 10 inch (254mm), 19 GA x 36 in (914mm)

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

Micro iBlade - 00857595005442 Catalog Number : 220497A

Device Description : Micro iBlade Sharp

Device Class : 1

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

Micro iBlade - 00857595005459 Catalog Number : 220497B

Device Description : Micro iBlade Blunt

Device Class : 1

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : GES

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005541 Catalog Number : 220517

Device Description : Cassette - Filter, Spike, and Neuraxial Connector

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005558 Catalog Number : 220517Y

Device Description : Cassette - Filter, Spike with Yellow Striped Tubing, and Neuraxial Connector

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005572 Catalog Number : 220244

Device Description : Continuous Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005589 Catalog Number : 220262

Device Description : PCA Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : MEA

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005596 Catalog Number : 220326

Device Description : PreSet Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

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