KENTEC MEDICAL, INC.

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

Tape And Bandage, Adhesive (KGX) (4) Tube, Feeding (FPD) (3) Warmer, Infant Radiant (FMT) (3)

Premarket Exempt

No Yes

Clear

Ameritus - 10817522010007 Catalog Number : AEG10-KMS

Device Description : 10ml enteral/oral syringe

Device Class :

Duns Number: 066175613

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010014 Catalog Number : 175

Device Description : 175 hydrogel probe cover

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010021 Catalog Number : 210

Device Description : ACCUTEMP DISP.SKIN PROBE#210(USE ON C100,C550) w/120P probe cover

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010038 Catalog Number : 230

Device Description : ACCU-TEMP PROBE #230 FOR USE W/OHMEDA w/120P probe cover

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010045 Catalog Number : 232

Device Description : OHMEDA GIRAFFE OMNI-BED COMPATIBLE TEMP.PROBE w/120P probe cover

Device Class : 2

Duns Number: 066175613

Premarket Exempt : No

Product Code : FMT

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010144 Catalog Number : 120P

Device Description : 120P medium size probe cover

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522010151 Catalog Number : ENF-40P-40

Device Description : 4fr 40cm 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 - 10817522010168 Catalog Number : 120S

Device Description : 120S small size probe cover

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1

Ameritus - 10817522010175 Catalog Number : 175-s

Device Description : 175-s small size hydrogel probe cover

Device Class :

Duns Number: 066175613

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : Yes

Device Count : 1

Ameritus ENFit - 10817522010182 Catalog Number : ENF-40P-50

Device Description : 4fr 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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