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) (9) Pump, Infusion, Pca (MEA) (3) Container, I.V. (KPE) (1)

Premarket Exempt

No Yes

Clear

ambIT - 00857595005602 Catalog Number : 220426

Device Description : PreSet Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005619 Catalog Number : 220452

Device Description : UMROI Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005626 Catalog Number : 220461

Device Description : PCRA Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005640 Catalog Number : 220468

Device Description : St. Luke's PreSet Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005664 Catalog Number : 220476

Device Description : RA PreSet Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005671 Catalog Number : 220437

Device Description : PCA Military Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005688 Catalog Number : 220501

Device Description : PIB*PCA Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN, MEA

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005695 Catalog Number : 220501Y

Device Description : Yellow PIB*PCA Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : MEA, FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005725 Catalog Number : 220523

Device Description : Cassette - Filter, Male Neuraxial Connector

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN, MEA

Prescription Use : Yes

Device Count : 1

MediBag - 00857595005732 Catalog Number : 220524

Device Description : MediBag - 250 mL with neuraxial connectors

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

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