KENTEC MEDICAL, INC.

Address:17871 FITCH,Irvine,CA,92614,US

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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

Tube, Feeding (FPD) (7) Tubes, Gastrointestinal (And Accessories) (KNT) (2) Utensil, Eating (ILC) (1)

Premarket Exempt

Yes No

Clear

Ameritus ENFit - 10817522012810 Catalog Number : ENF-EXT-Y060

Device Description : 60" enteral extension set w/ dual ENFit connectors

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522012827 Catalog Number : ENF-Straw

Device Description : Enfit syringe straw

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : ILC

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522012834 Catalog Number : ENF-EXT-022

Device Description : 22" enteral extension set w/ENFit connectors

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013022 Catalog Number : ENF-Y60P-90

Device Description : 6fr 90cm dual port feeding tube with ENFit connectors

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013039 Catalog Number : ENF-Y80P-90

Device Description : 8fr 90cm dual port feeding tube with ENFit connectors

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013046 Catalog Number : ENF-100P-110

Device Description : 10fr 110cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013060 Catalog Number : ENF-40P-90

Device Description : 4fr 90cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013077 Catalog Number : ENF-50P-50U

Device Description : 5fr 50cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013084 Catalog Number : ENF-60P-50U

Device Description : 6fr 50cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522013091 Catalog Number : ENF-80P-50U

Device Description : 8fr 50cm single port feeding tube with ENFit connector

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

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