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

Set, I.V. Fluid Transfer (LHI) (10)

Premarket Exempt

No Yes

Clear

KENAFLEXX - 00810003750006 Catalog Number : 937015

Device Description : IV ADMINISTRATION SET, 78", 15 DROPS/ML, ONE KEN_SEF SPLIT SEPTUM Y CONNECTOR, N

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750013 Catalog Number : 937020

Device Description : IV ADMINISTRATION SET, 100", 20 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, IN LINE SO

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750020 Catalog Number : 937029

Device Description : IV ADMINISTRATION SET, 92", 20 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, KENTRON GRA

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750037 Catalog Number : 937025

Device Description : IV ADMINISTRATION SET, 92", VENTED SPIKE, DRIP CHAMBER, IN LINE FILTER, KEN_SEF

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750044 Catalog Number : 937016

Device Description : IV ADMINISTRATION SET, 85", 15 DROPS/ML, VENTED SPIKE, DRIP CHAMBER, FLOW REGULA

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750051 Catalog Number : 937062

Device Description : IV ADMINISTRATION SET, 78", VENTED SPIKE, DRIP CHAMBER, FLOW REGULATOR, 2 KEN_SE

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750068 Catalog Number : 937063

Device Description : IV ADMINISTRATION SET, 75", DRIP CHAMBER, FLOW REGULATOR, KEN_ROL MAME ROTATING

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750075 Catalog Number : 940012

Device Description : 12" IV EXTENSION SET WITH FEMALE LUER, KENTRON GRAVITO FLOW REGULATOR, ONE KEN_S

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750082 Catalog Number : 940013

Device Description : 12" IV EXTENSIO SET WITH FEMALE LUER CONNECTOR, KENTRON GRAVITO FLOW CONTROLLER,

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

KENAFLEXX - 00810003750099 Catalog Number : 940014

Device Description : 12" IV EXTENSION SET WITH FEMALE LUER, KENTRON GRAVITO FLOW CONTROLLER, ONE KEN_

Device Class : 2

Duns Number: 618825723

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

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