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

Tubing, fluid delivery (FPK) (4) Set, administration, intravascular (FPA) (3) Tubes, gastrointestinal (and accessories) (KNT) (2) Filter, infusion line (FPB) (1)

Premarket Exempt

No Yes

Clear

VYGON - 10849884001874 Catalog Number : 828.88

Device Description : ORAL SYRINGE TIP ADAPTER FOR SAFETY CONNECTION NUTRISAFE 2

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

VYGON - 10849884002260 Catalog Number : 75800301

Device Description : 40" AD-MIX SET NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 10849884002383 Catalog Number : 828.66

Device Description : SYRINGE CAP FOR SAFETY CONNECTION NUTRISAFE 2

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

VYGON - 10849884002536 Catalog Number : AMS-290NS

Device Description : LARGE VIAL ACCESS SPIKE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884002581 Catalog Number : AMS-395-1-NS

Device Description : 14" MINIBORE EXTENSION SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 10849884002604 Catalog Number : AMS-427-NS

Device Description : 7" MINIBORE EXTENSION SET WITH 0.2 MICRON FILTER

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPB

Prescription Use : No

Device Count : 1

VYGON - 10849884002659 Catalog Number : AMS-483CNS

Device Description : 36" ULTRA-MICROBORE EXTENSION SET NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884002666 Catalog Number : AMS-483NS

Device Description : 36" ULTRA-MICROBORE EXTENSION SET NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 10849884002697 Catalog Number : AMS-500NS

Device Description : SMALL VIAL ACCESS DEVICE NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884002765 Catalog Number : AMS-555-1-NS

Device Description : 30" STANDARDBORE EXTENSION SET WITH 3-WAY STOPCOCK NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

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