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) (10)

Premarket Exempt

No Yes

Clear

KENOREX - 00851785007469 Catalog Number : 769950

Device Description : ENDOTRACHEAL TUBE CUFFED 5.0 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007476 Catalog Number : 769955

Device Description : ENDOTRACHEAL TUBE CUFFED 5.5 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007483 Catalog Number : 769960

Device Description : ENDOTRACHEAL TUBE CUFFED 6.0 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007490 Catalog Number : 769965

Device Description : ENDOTRACHEAL TUBE CUFFED 6.5 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007506 Catalog Number : 769970

Device Description : ENDOTRACHEAL TUBE CUFFED 7.0 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007513 Catalog Number : 769975

Device Description : ENDOTRACHEAL TUBE CUFFED 7.5 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007537 Catalog Number : 769980

Device Description : ENDOTRACHEAL TUBE CUFFED 8.0 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007544 Catalog Number : 769985

Device Description : ENDOTRACHEAL TUBE CUFFED 8.5 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007551 Catalog Number : 769990

Device Description : ENDOTRACHEAL TUBE CUFFED 9.0 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

KENOREX - 00851785007568 Catalog Number : 769995

Device Description : ENDOTRACHEAL TUBE CUFFED 9.5 MM WITH STYLET MURPHY EYE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTR

Prescription Use : No

Device Count : 1

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