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) (5) Peripheral catheter insertion kit (OWL) (3) Nerve block tray (OGJ) (1) SCISSORS, MEDICAL, DISPOSABLE (JOK) (1)

Premarket Exempt

No Yes

Clear

VYGON - 08498840012901 Catalog Number : AMS-588

Device Description : 7" MICROBORE QUADFURCATED EXTENSION SET WITH 3 0.22 MICRON FILTERS

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 08498840012932 Catalog Number : AMS-945

Device Description : 6" BIFURCATED EXTENSION SET WITH 0.2 MICRON FILTER

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 08498840012949 Catalog Number : AMS-944

Device Description : 6" MICROBORE TRIFURCATED EXTENSION SET WITH MALE/FEMALE LUER LOCKS, SLIDE CLAMBS 6" MICROBORE TRIFURCATED EXTENSION SET WITH MALE/FEMALE LUER LOCKS, SLIDE CLAMBS, AND 0.2 MICRON FILTER

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 08498840012970 Catalog Number : AMS-375-1

Device Description : 6" MICROBORE TRIFURCATED EXTENSION SET WITH TWO BIONECTORS AND 0.2 MICRON FILTER

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 08498840012987 Catalog Number : AMS-519-1

Device Description : TRIFURCATED EXTENSION SET WITH CHECK VALVES

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 08498840013021 Catalog Number : AMS-9008-1

Device Description : BONE MARROW PROCEDURE KIT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : OWL

Prescription Use : No

Device Count : 1

VYGON - 08498840013076 Catalog Number : AMS-9059CP

Device Description : NERVE BLOCK CATHETER KIT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : OGJ

Prescription Use : No

Device Count : 1

VYGON - 08498840013151 Catalog Number : AMS-750

Device Description : SOLUTIONS ACCESSORY KIT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : OWL

Prescription Use : No

Device Count : 1

VYGON - 08498840013168 Catalog Number : AMS-8405CP-3

Device Description : DRESSING CHANGE KIT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : OWL

Prescription Use : No

Device Count : 1

VYGON - 10849884001157 Catalog Number : AMS-850TCNS

Device Description : V-CUTTER CATHETER TRIMMING TOOL 2FR-6FR

Device Class : 1

Duns Number: 120818216

Premarket Exempt : Yes

Product Code : JOK

Prescription Use : No

Device Count : 1

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