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) (10)

Premarket Exempt

No Yes

Clear

VYGON - 10849884002796 Catalog Number : AMS-596-2

Device Description : 12" SMALLBORE EXTENSION SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884002840 Catalog Number : AMS-636NS

Device Description : 60" MICROBORE EXTENSION SET NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884002864 Catalog Number : AMS-664-2

Device Description : 6" SMALLBORE EXTENSION SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003021 Catalog Number : AMS-761NS

Device Description : 7" MICROBORE EXT. SET WITH MALE/FEMALE LUER LOCKS & SLIDE CLAMP NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003250 Catalog Number : AMS-879

Device Description : 6" MICROBORE EXTENSION SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003267 Catalog Number : AMS-879-2

Device Description : 12" SMALLBORE EXTENSION SET W/CLAMP

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003298 Catalog Number : AMS-892C-NS

Device Description : 4" MICROBORE EXTENSION SET NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003694 Catalog Number : BN-300NS

Device Description : VIAL ACCESS SPIKE WITH NEEDLELESS CONNECTOR BIONECTOR NON-STERILE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003915 Catalog Number : CMS-02

Device Description : 72" VENTED/NON-VENTED FLUID DELIVERY SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 10849884003922 Catalog Number : CMS-03

Device Description : 72" NON-VENTED FLUID DELIVERY SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

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