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) (8) Container, I.V. (KPE) (2)

Premarket Exempt

No Yes

Clear

ambIT - 00857595005039 Catalog Number : 220139

Device Description : Cassette - Filterless, Spike

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005046 Catalog Number : 220140

Device Description : Cassette - Filter, Spike

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005053 Catalog Number : 220140B

Device Description : Cassette - Filter, Spike with Blue Striped Tubing

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005060 Catalog Number : 220140Y

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

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005077 Catalog Number : 220266

Device Description : Cassette - Filter, Male Luer

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005084 Catalog Number : 220266Y

Device Description : Cassette - Filter, Male Luer

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005091 Catalog Number : 220267

Device Description : Cassette - Filterless, Male Luer

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

ambIT - 00857595005107 Catalog Number : 220514Y

Device Description : Cassette - Filter, Spike with Yellow Stripe Tubing

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : FRN

Prescription Use : Yes

Device Count : 1

MediBag - 00857595005114 Catalog Number : 220121

Device Description : MediBag - 250 mL

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

MediBag - 00857595005121 Catalog Number : 220278

Device Description : MediBag - 420 mL

Device Class : 2

Duns Number: 831704841

Premarket Exempt : No

Product Code : KPE

Prescription Use : Yes

Device Count : 1

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