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

Blood Pressure Cuff (DXQ) (5) Nebulizer (Direct Patient Interface) (CAF) (5)

Premarket Exempt

No Yes

Clear

KENAFLEXX - 00866512000255 Catalog Number : 177805D

Device Description : NON INVASIVE BLOOD PRESSURE NYLON CUFF NEONATE #5 DOUBLE TUBE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00866512000262 Catalog Number : 177806D

Device Description : NON INVASIVE BLOOD PRESSURE NYLON CUFF NEW BORN DOUBLE TUBE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00866512000279 Catalog Number : 177807D

Device Description : NON INVASIVE BLOOD PRESSURE NYLON CUFF INFANT DOUBLE TUBE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00866512000286 Catalog Number : 177808D

Device Description : NON INVASIVE BLOOD PRESSURE NYLON CUFF SMALL CHILD DOUBLE TUBE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00866512000293 Catalog Number : 177809D

Device Description : NON INVASIVE BLOOD PRESSURE NYLON CUFF CHILD DOUBLE TUBE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

KENOREX - 10852244007294 Catalog Number : 333752

Device Description : NEBULIZER SMALL VOLUME WITH T-PIECE AND OXYGEN TUBING

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

KENOREX - 10852244007300 Catalog Number : 333759

Device Description : NEBULIZER SMALL VOLUME WITH T-PIECE AND CORRUGATED TUBE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

KENOREX - 10852244007317 Catalog Number : 333760

Device Description : NEBULIZER WITH ADULT OXYGEN MASK AND OXYGEN TUBING

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

KENOREX - 10852244007324 Catalog Number : 333761

Device Description : NEBULIZER WITH CHILD OXYGEN MASK AND OXYGEN TUBING

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

KENOREX - 10852244007331 Catalog Number : 333762

Device Description : NEBULIZER CIRCUIT TYPE I

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

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