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) (4) Tubing, fluid delivery (FPK) (3) Dressing change tray (OXQ) (2) I.V. start kit (LRS) (1)

Premarket Exempt

No Yes

Clear

VYGON - 00849884000528 Catalog Number : AMS-435CV-1

Device Description : 45" MICROBORE EXTENSION SET WITH ANTISIPHON VALVE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000535 Catalog Number : AMS-440

Device Description : 4" MICROBORE EXTENSION SET WITH MALE LUER SLIP T-PORT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000542 Catalog Number : AMS-635CV-1

Device Description : 60" MICROBORE EXTENSION SET WITH ANTISIPHON VALVE AND 2 MALE LUER LOCKS

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000559 Catalog Number : CMS-396

Device Description : 14" MICROBORE EXTENSION SET WITH NEEDLELESS CONNECTOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000566 Catalog Number : SS-395B

Device Description : 14" EXTENSION SET W/NEEDLELESS Y-SITE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000573 Catalog Number : AMS-620FC

Device Description : 84" ADMINISTRATION SET WITH 20 DROPS/ML SPIKE DRIP CHAMBER

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000580 Catalog Number : AMS-934-1

Device Description : 60" MICROBORE ENTERNAL SET W/ORAL SYRINGE ADAPTOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000597 Catalog Number : AMS-845CS-3

Device Description : IV START KIT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : LRS

Prescription Use : No

Device Count : 1

VYGON - 00849884000603 Catalog Number : AMS-9275CP-2

Device Description : DRESSING CHANGE KIT

Device Class : 1

Duns Number: 120818216

Premarket Exempt : No

Product Code : OXQ

Prescription Use : No

Device Count : 1

VYGON - 00849884000610 Catalog Number : AMS-7870CP-21

Device Description : DRESSING CHANGE KIT

Device Class : 1

Duns Number: 120818216

Premarket Exempt : No

Product Code : OXQ

Prescription Use : No

Device Count : 1

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