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

Tubes, Gastrointestinal (And Accessories) (KNT) (5) Electrode, Electrocardiograph (DRX) (2) Tube, Feeding (FPD) (2) Splint, Extremity, Non-Inflatable, External, Non-Sterile (NOC) (1)

Premarket Exempt

Yes No

Clear

Kentec ArmBoard - 10817522010328 Catalog Number : 405ABV

Device Description : 405 size armboard with velcro strap

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : NOC

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010359 Catalog Number : AMG-503-LG

Device Description : large size ecg electrode

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010366 Catalog Number : AMG-503-SM

Device Description : small size ecg electrode

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : DRX

Prescription Use : Yes

Device Count : 1

IV extension set - 10817522010465 Catalog Number : KMI436

Device Description : codan set

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

IV extension set - 10817522010472 Catalog Number : KMI467C

Device Description : codan set

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

IV extension set - 10817522010489 Catalog Number : KMI483C

Device Description : codan set

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

IV extension set - 10817522010496 Catalog Number : KMI636

Device Description : codan set

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

IV extension set - 10817522010519 Catalog Number : KMI959

Device Description : codan set

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : KNT

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522010526 Catalog Number : ENF-60P-90

Device Description : 6fr 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 - 10817522010533 Catalog Number : ENF-80P-90

Device Description : 8fr 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

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