ZEVEX INTERNATIONAL, INC.

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) (10)

Premarket Exempt

No

Clear

Infinity Enteral Feeding Pump - 10814844000075 Catalog Number : INFKIT2

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : Yes

Device Count : 1

Infinity - 10814844000099 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 - 10814844000105 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 - 10814844000112 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

Infinity - 10814844000129 Catalog Number : 50745-003

Device Description : Enteralite Infinity Mini Backpack, Black

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : No

Device Count : 1

Infinity - 10814844000136 Catalog Number : 50749-001

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 - 10814844000143 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 - 10814844000150 Catalog Number : 50751

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

Infinity - 10814844000167 Catalog Number : 50753

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 Enteral Feeding Pump - 10814844000174 Catalog Number :

Device Class : 2

Duns Number: 612746933

Premarket Exempt : No

Product Code : LZH

Prescription Use : Yes

Device Count : 1

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