Vygon Corporation

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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, administration, intravascular (FPA) (7) Tubing, fluid delivery (FPK) (2) Filter, infusion line (FPB) (1)

Premarket Exempt

No Yes

Clear

VYGON - 00849884000320 Catalog Number : SS-112-1

Device Description : 17" STANDARDBORE EXT SET W/NEEDLELESS INJECTION SITE, FLOW REGULATOR, MLL/FLL & CLAMP

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000337 Catalog Number : SS-426

Device Description : 14" STANDARDBORE EXTENSION SET WITH 0.2 MICRON FILTER AND NEEDLELESS Y-SITE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPB

Prescription Use : No

Device Count : 1

VYGON - 00849884000344 Catalog Number : BN-602

Device Description : 105" ADMINISTRATIONSET W/ BIONECTOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000351 Catalog Number : KS-975-2

Device Description : 84" ADMIN SET WITH 20 DROPS/ML SPIKE DRIP CHAMBER, 0.2 MICRON FILTER AND NEEDLELESS Y-SITE

Device Class :

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000368 Catalog Number : KS-975NF-2

Device Description : 84" ADMINISTRATION SET WITH 20 DROPS/ML SPIKE DRIP CHAMBER AND NEEDLELESS Y-SITE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000375 Catalog Number : AMS-282-3

Device Description : 10" STNDBORE EXT SET WITH ROTATING MALE LUER, FLL, SLIDE CLAMP & NEEDLELESS INJ SITE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000382 Catalog Number : KS-122-2

Device Description : 84" ADMINISTRATION SET W 20 DROPS/ML SPIKE DRIP, NEEDLELESS Y-SITE & FLOW REGULATOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000399 Catalog Number : KS-222-2

Device Description : 90" PRIMARY SOLUTION SET W/UNIV SPIKE, (2) INJ SITES, FLOW REGULATOR & ROTATING MLL

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000405 Catalog Number : AMS-410

Device Description : 84" STANDARDBORE IV SET W/ 1.2 FILTER , FLOW CONTROLLER, & NEEDLELESS CONNECTOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000412 Catalog Number : SS-933-1

Device Description : 115" ADMINISTRATION SET WITH 15 DROP/ML SPIKE DRIP CHAMBER AND THREE NEEDLELESS Y-SITES

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

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