ZEVEX INTERNATIONAL, 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

Gastrointestinal Tubes With Enteral Specific Connectors (PIF) (5) Pump, Infusion, Enteral (LZH) (5)

Premarket Exempt

Clear

Infinity - 10814844001645 Catalog Number :

Device Description : Enteralite Infinity Adult Pack, Black

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity 1200 mL Feeding Bag Set with Enfit Connector - 10814844001959 Catalog Number : INF1200-E

Device Description : Infinity 1200 mL Feeding Bag Set with Enfit Connector

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

GR 1200 mL Feeding Bag Set with Enfit Connector - 10814844001966 Catalog Number : GR1200-E

Device Description : GR 1200 mL Feeding Bag Set with Enfit Connector

Device Class :

Duns Number: 612746933

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

Infinity 100 mL Feeding Bag Set with Enfit Connector - 10814844001973 Catalog Number : INF0100-E

Device Description : Infinity 100 mL Feeding Bag Set with Enfit Connector

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

Infinity Spike Set with Enfit Connector - 10814844001980 Catalog Number : INF0020-E

Device Description : Infinity Spike Set with Enfit Connector

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

Infinity Low Volume Screw Cap Set with Enfit Connector - 10814844001997 Catalog Number : INFOCAP-E

Device Description : Infinity Low Volume Screw Cap Set with Enfit Connector

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : PIF

Prescription Use : Yes

Device Count : 1

Infinity Enteral Feeding Pump - 18148440000071 Catalog Number : INFKIT2

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : Yes

Device Count : 1

Infinity - 18148440000095 Catalog Number : 50744

Device Description : Enteralite Infinity AC Adapter/charger

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 18148440000101 Catalog Number : 50745-001

Device Description : Enteralite Infinity Mini Backpack, Red

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 18148440000118 Catalog Number : 50745-002

Device Description : Enteralite Infinity Mini Back Pack, Green/Gray

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

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