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) (6) Tubing, fluid delivery (FPK) (3) Filter, infusion line (FPB) (1)

Premarket Exempt

No Yes

Clear

VYGON - 00849884000429 Catalog Number : AMS-122-1

Device Description : 84" ADMINISTRATION SET WITH 20 DROPS/ml SPIKE DRIP CHAMBER, FLOW REGULATOR AND Y-SITE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000436 Catalog Number : AMS-292-2

Device Description : 84" ADMIN SET W 20 DROPS/ML SPIKE DRIP CHAMBER, FLOW REG, 0.2 MICRON FILTER & NE 84" ADMIN SET W 20 DROPS/ML SPIKE DRIP CHAMBER, FLOW REG, 0.2 MICRON FILTER & NEEDLESS Y-SITE

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000443 Catalog Number : AMS-105-1

Device Description : 105" ADMIN SET WITH 20 DROPS/ml SPIKE DRIP CHAMBER, CHECK VALVE AND 2 NEEDLELESS Y-SITES

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000450 Catalog Number : AMS-609-1

Device Description : 105" ADMIN SET W 20 DROPS/ML SPIKE DRIP CHAMBER, 0.22 MICRON FILTER, CHECK VALVE 105" ADMIN SET W 20 DROPS/ML SPIKE DRIP CHAMBER, 0.22 MICRON FILTER, CHECK VALVE & 2 Y-SITES

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000467 Catalog Number : AMS-615

Device Description : 105" ADMINISTRATION SET WITH 20 DROPS/ML SPIKE DRIP CHAMBER, CHECK VALVE, AND 2 Y-SITES

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPK

Prescription Use : No

Device Count : 1

VYGON - 00849884000474 Catalog Number : SS-761B

Device Description : 7" MICROBORE EXTENSION SET WITH NEEDLELESS CONNECTOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000481 Catalog Number : SSP-395

Device Description : 14" MINIBORE EXTENSION SET WITH NEEDLELESS CONNECTOR

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000498 Catalog Number : AMS-391

Device Description : 38" MICROBORE EXTENSION SET WITH T-PORT

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

VYGON - 00849884000504 Catalog Number : AMS-427

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 - 00849884000511 Catalog Number : AMS-428

Device Description : 60" ULTRA-MICROBORE EXTENSION SET WITH 0.22 MICRON FILTER

Device Class : 2

Duns Number: 120818216

Premarket Exempt : No

Product Code : FPA

Prescription Use : No

Device Count : 1

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