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

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (6) Nebulizer (Direct Patient Interface) (CAF) (2) Attachment, Breathing, Positive End Expiratory Pressure (BYE) (1) Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (1)

Premarket Exempt

Yes No

Clear

KENOREX - 10852244007348 Catalog Number : 333763

Device Description : NEBULIZER CIRCUIT TYPE II

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

KENOREX - 10852244007355 Catalog Number : 333764

Device Description : NEBULIZER CIRCUIT TYPE III

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

KENOREX - 10852244007362 Catalog Number : 779504

Device Description : RESUSCITATOR MANOMETER 0-60 CMS WATER 30 MM ID

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAP

Prescription Use : No

Device Count : 1

KENOREX - 10852244007379 Catalog Number : 712320

Device Description : PEEP VALVE DISPOSABLE 5-20 CMS WATER PRESSURE, 30 MM ID

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : BYE

Prescription Use : No

Device Count : 1

KENTRON CAPNOGRAPHY - 10852244007386 Catalog Number : 587300

Device Description : OXYGEN NASAL CANNULA ADULT 7FT TUBE, W/CO2 SAMPLING LINE (MALE LUER)

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

KENTRON CAPNOGRAPHY - 10852244007393 Catalog Number : 587400

Device Description : OXYGEN NASAL CANNULA CHILD 7FT TUBE, W/CO2 SAMPLING LINE (MALE LUER)

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

KENTRON CAPNOGRAPHY - 10852244007409 Catalog Number : 587500

Device Description : OXYGEN NASAL CANNULA INFANT 7FT TUBE, W/CO2 SAMPLING LINE (MALE LUER)

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

KENTRON CAPNOGRAPHY - 10852244007416 Catalog Number : 687305

Device Description : NASAL CANNULA ADULT 7FT TUBE, W/CO2, SAMPLING LINE (FEMALE LUER)

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

KENTRON CAPNOGRAPHY - 10852244007423 Catalog Number : 687405

Device Description : NASAL CANNULA CHILD 7FT TUBE, W/CO2, SAMPLING LINE (FEMALE LUER)

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

KENTRON CAPNOGRAPHY - 10852244007430 Catalog Number : 687505

Device Description : NASAL CANNULA INFANT 7FT TUBE, W/CO2, SAMPLING LINE (FEMALE LUER)

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CCK

Prescription Use : No

Device Count : 1

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