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KENTEC MEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 17871 FITCH, Irvine, CA, 92614
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2080225
DUNS Number: —

Catalogue (243)

Page 2 of 5

Device	Model / Reference	Registries	Class	Status
Ameritus	AEG3-KMS	FDA UDI	Class II	Active
Ameritus ENFit	ENF-50P-110	FDA UDI	Class II	Active
Ameritus	AEG-Y50P-40	FDA UDI	Class II	Active
Ameritus	AEG1-KMS	FDA UDI	Class II	Active
IV extension set	KMI483C	FDA UDI	Class II	Active
Ameritus	AEG-60P-90	FDA UDI	Class II	Active
Ameritus	AEG-Y50P-50	FDA UDI	Class II	Active
Ameritus Oral Syringe	AEG3-KMS-BA	FDA UDI	Class I	Active
Ameritus	120S	FDA UDI	Class I	Active
Ameritus	AEG-Y80P-50	FDA UDI	Class II	Active
Ameritus	AEG-80P-80	FDA UDI	Class II	Active
Ameritus ENFit	ENF1-KMS-LD	FDA UDI	Class II	Active
Ameritus	230	FDA UDI	Class II	Active
Ameritus	AEG-100P-80	FDA UDI	Class II	Active
Ameritus ENFit	ENF-60P-40	FDA UDI	Class II	Active
Ameritus ENFit	ENF1-KS-LDBC	FDA UDI	Class II	Active
Ameritus ENFit	ENF-80P-80	FDA UDI	Class II	Active
Ameritus Oral Syringe	AEG10-KMS-BA	FDA UDI	Class I	Active
Ameritus ENFit	ENF-50P-50U	FDA UDI	Class II	Active
Ameritus	AEG-Y60P-90	FDA UDI	Class II	Active
IV extension set	KMI959	FDA UDI	Class II	Active
Ameritus	AEG-80S-50	FDA UDI	Class II	Active
Ameritus	AEG-80P-90	FDA UDI	Class II	Active
Swabeze	KMI-65	FDA UDI	Class I	Active
Ameritus Transducer	RATG-100-U	FDA UDI	Class II	Active
Ameritus Transducer	RATG-302-T	FDA UDI	Class II	Active
Ameritus	AEG-1SC-060	FDA UDI	Class II	Active
Ameritus ENFit	ENF-Y80P-90U	FDA UDI	Class II	Active
Ameritus Transducer	ATG-WAVE-UB	FDA UDI	Class II	Active
Ameritus	AEG-Y60P-40	FDA UDI	Class II	Active
AccuTemp Probe	232H	FDA UDI	Class II	Active
Ameritus	AEG-120P-80	FDA UDI	Class II	Active
Ameritus Transducer	RATG-100-T	FDA UDI	Class II	Active
Ameritus ENFit	ENF-EXT-036	FDA UDI	Class II	Active
Ameritus	AEG-50P-40	FDA UDI	Class II	Active
Ameritus	AEG-Y100P-80	FDA UDI	Class II	Active
Ameritus Oral Syringe	AEG5-KMS-BA	FDA UDI	Class I	Active
Ameritus ENFit	ENF3-KS-LDBC	FDA UDI	Class II	Active
Ameritus ENFit	ENF20-KSBA	FDA UDI	Class II	Active
Ameritus	AEG-60P-40	FDA UDI	Class II	Active
Ameritus ENFit	ENF-EXT-022	FDA UDI	Class II	Active
Ameritus	AEG-Y50P-90	FDA UDI	Class II	Active
Ameritus ENFit	ENF-80P-90	FDA UDI	Class II	Active
Ameritus	AEG-100P-110	FDA UDI	Class II	Active
Ameritus	AEG20-KMS	FDA UDI	Class II	Active
Ameritus ENFit	ENF60-KMS	FDA UDI	Class II	Active
Hummi Micro-Draw	ABG-HM-1	FDA UDI	Class I	Active
Ameritus ENFit	ENF-EXT-Y060	FDA UDI	Class II	Active
Ameritus	AEG30-KMS	FDA UDI	Class II	Active
Kentec ArmBoard	405AB	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Authorities

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FDA Recalls (10)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 17, 2020	Z-2514-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2517-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2516-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2518-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2519-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2520-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jan 17, 2020	Z-2515-2020	—	terminated	Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could be unnecessarily overexposed to radiation if multiple x-rays are needed to confirm placement of a new tube, if x-ray is used as the placement confirmation method.
Jun 23, 2017	Z-3073-2017	—	terminated	Inadequate detectability of radiopaque stripes
Jun 23, 2017	Z-3074-2017	—	terminated	Inadequate detectability of radiopaque stripes
May 18, 2007	Z-1188-2008	—	terminated	Incompatible components: The Finger Clip Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 - are missing an additional diode and higher resistor in its existing configuration making them inoperable when used to interface with those Ohmeda Tuffsat monitors previously re-configured by Ohmeda to include a detection circuit for diodes.