Vygon Corporation

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) Catheter, intravascular, therapeutic, short-term less than 30 days (FOZ) (3) Tubing, fluid delivery (FPK) (2)

Premarket Exempt

No Yes

Clear

VYGON - 00849884000016 Catalog Number : AMS-656

Device Description : BAG ACCESS DEVICE WITH TEXIUM VALVE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000030 Catalog Number : VYLF2006

Device Description : 6CM LEADERFLEX BASIC INSERTION TRAY

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FOZ

Prescription Use : No

Device Count : 1

VYGON - 00849884000047 Catalog Number : VYLF2004

Device Description : 4CM LEADERFLEX BASIC INSERTION TRAY

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FOZ

Prescription Use : No

Device Count : 1

VYGON - 00849884000054 Catalog Number : VYLF2008

Device Description : 8CM LEADERFLEX BASIC INSERTION TRAY

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FOZ

Prescription Use : No

Device Count : 1

VYGON - 00849884000269 Catalog Number : AMS-184-1

Device Description : 35" STANDARDBORE PIGGYBACK SECONDARY ADMIN. SET W/UNIVERSAL DRIP CHAMBER & SPIKE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000276 Catalog Number : AMS-975-1

Device Description : 84" ADMINISTRATION SET WITH UNIVERSAL SPIKE .22 MICRON FILTER, INJECTION SITE & MALE LL

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000283 Catalog Number : AMS-295-1

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 - 00849884000290 Catalog Number : AMS-541

Device Description : 105" ADMINISTRATION SET

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000306 Catalog Number : AMS-975NF

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

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000313 Catalog Number : AMS-555-1

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

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

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