KENTRON HEALTHCARE, INC.

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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

Set, I.V. Fluid Transfer (LHI) (5) Ventilator, Emergency, Manual (Resuscitator) (BTM) (3) Valve, Non-Rebreathing (CBP) (2)

Premarket Exempt

No Yes

Clear

KENAFLEXX - 00852244007846 Catalog Number : 940020

Device Description : IV EXTENSION SET WITH KEN_SEF SPLIT SEPTUN Y CONNECTOR, KEN_ROL MALE ROTATING LU IV EXTENSION SET WITH KEN_SEF SPLIT SEPTUN Y CONNECTOR, KEN_ROL MALE ROTATING LUER LOCK CENNECTOR, FLOW REGULATOR.

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00852244007853 Catalog Number : 940035

Device Description : IV EXTENSION SET, 35" WITH FEMALE LUER CONNECTOR, KEN_ROL MALE ROTATING LUER LOC IV EXTENSION SET, 35" WITH FEMALE LUER CONNECTOR, KEN_ROL MALE ROTATING LUER LOCK CONNECTOR AND FLOW REGULATOR,

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00852244007860 Catalog Number : 950006

Device Description : 6" EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK CONNECTOR AND THRE 6" EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK CONNECTOR AND THREE WAY STOP COCK.

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00852244007877 Catalog Number : 950020

Device Description : 20" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK, FLOW BCONTROL 20" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK, FLOW BCONTROLLER AND THREE WAY STOP COCK.

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00852244007884 Catalog Number : 950035

Device Description : 35" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK CONNECTOR AND 35" IV EXTENSION SET WITH FEMALE LUER AND ROTATING MALE LUER LOCK CONNECTOR AND THREE WAY STOP COCK.

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENOREX - 00866512000200 Catalog Number : 779500

Device Description : PULMONARY RESUSCITATOR, MANUAL

Device Class :

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

KENOREX - 00866512000217 Catalog Number : 779501

Device Description : PULMONARY RESUSCITATOR, MANUAL FOR CHILDREN

Device Class :

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

KENOREX - 00866512000224 Catalog Number : 779502

Device Description : PULMONARY RESUSCITATOR, MANUAL FOR INFANTS

Device Class :

Duns Number: 618825723

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

KENOREX - 00866512000231 Catalog Number :

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

KENOREX - 00866512000248 Catalog Number :

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

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