SUMMIT MEDICAL PRODUCTS, INC.

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) (5) Pump, Infusion (FRN) (3) Pump, Infusion, Pca (MEA) (3) Catheter, Conduction, Anesthetic (BSO) (1) Container, I.V. (KPE) (1)

Premarket Exempt

No Yes

Clear

ambIT - 00850000509009 Catalog Number : 220568

Device Description : ambIT Kit Basic w Male Luer & Filter Cassette

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509016 Catalog Number : 220569

Device Description : ambIT Kit Basic w Spike & Filter Cassette

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509023 Catalog Number : 220546

Device Description : PIB*PCA v1.5 Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN, MEA

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509030 Catalog Number : 220572

Device Description : PIB*PCA v1.5 Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN, MEA

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509047 Catalog Number : 220573

Device Description : PIB/PCA v1.5 Pain Control System-Basic

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509054 Catalog Number : 220574

Device Description : PIB/PCA v1.5 Pain Control System-Basic

Device Class :

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509061 Catalog Number : 220575

Device Description : ambIT Kit Basic w Spike & Filter Cassette

Device Class : 2

Duns Number: 831704841

Premarket Exempt : Yes

Product Code : OFQ

Prescription Use : Yes

Device Count : 1

ambIT - 00850000509078 Catalog Number : 220571

Device Description : PIB*IL v1.5 Pump

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN, MEA

Prescription Use : Yes

Device Count : 1

MediBag - 00850000509238 Catalog Number : 220582

Device Description : MediBag 420 ml w/ Nuraxial Connector

Device Class :

Duns Number: 831704841

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005022 Catalog Number : 220418

Device Description : Introducer- 8 inch

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : BSO

Prescription Use : Yes

Device Count : 1

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