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

Pump, Infusion, Enteral (LZH) (8) Gastrointestinal Tubes With Enteral Specific Connectors (PIF) (1) Pump, Infusion (FRN) (1)

Premarket Exempt

Clear

Curlin - 10814844001010 Catalog Number : 56872

Device Description : Curlin Bolus Cord

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : FRN

Prescription Use : No

Device Count : 1

Infinity 500 mL Feeding Bag Set with Enfit Connector - 10814844001522 Catalog Number : INF0500-E

Device Description : Infinity 500 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 Pole Clamp - 10814844001553 Catalog Number : 29152-001

Device Description : Enteralite Infinity Adjustable Pole Clamp

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 10814844001577 Catalog Number : 23401-001

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 - 10814844001584 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 - 10814844001591 Catalog Number :

Device Description : Enteralite Infinity Mini Backpack, Gray/Green

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 10814844001607 Catalog Number :

Device Description : Enteralite Infinity Mini Backpack, Black/Gray

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 10814844001614 Catalog Number :

Device Description : Enteralite Infinity Super Mini Backpack, Black

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 10814844001621 Catalog Number : 50749-001

Device Description : Enteralite Infinity Super Mini Backpack, Green/Gray

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 10814844001638 Catalog Number :

Device Description : Enteralite Infinity Waist Pack, Black

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

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