KENTRON HEALTHCARE, 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

Tube, Tracheal (W/Wo Connector) (BTR) (9) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

KenTemp - 00810003751850 Catalog Number : DT3334

Device Description : Digital Thermometer

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

KENOREX - 00851785007001 Catalog Number : 739920

Device Description : ENDOTRACHEAL TUBE UNCUFFED 2.0 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007018 Catalog Number : 739925

Device Description : ENDOTRACHEAL TUBE UNCUFFED 2.5 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007025 Catalog Number : 739930

Device Description : ENDOTRACHEAL TUBE UNCUFFED 3.0 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007032 Catalog Number : 739935

Device Description : ENDOTRACHEAL TUBE UNCUFFED 3.5 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007049 Catalog Number : 739940

Device Description : ENDOTRACHEAL TUBE UNCUFFED 4.0 MM MURPHY EYE

Device Class :

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007056 Catalog Number : 739945

Device Description : ENDOTRACHEAL TUBE UNCUFFED 4.5 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007063 Catalog Number : 739950

Device Description : ENDOTRACHEAL TUBE UNCUFFED 5.0 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007070 Catalog Number : 739955

Device Description : ENDOTRACHEAL TUBE UNCUFFED 5.5 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007087 Catalog Number : 739960

Device Description : ENDOTRACHEAL TUBE UNCUFFED 6.0 MM MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

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