VYGON

Address:5-11 RUE ADELINE,ECOUEN 95440 Val-d'Oise,FR

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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

CATHETER, UMBILICAL ARTERY (FOS) (3) TUBE, FEEDING (FPD) (3) CONNECTOR, AIRWAY (EXTENSION) (BZA) (2) Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass (DTL) (1) CATHETERS, SUCTION, TRACHEOBRONCHIAL (BSY) (1)

Premarket Exempt

No Yes

Clear

VYGON - 03660812129985 Catalog Number : 362.122

Device Description : Nutrisafe2 - 12Fr - L.125cm - PVC

Device Class :

Duns Number: 392994778

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

VYGON - 03660812130196 Catalog Number : 1274.17

Device Description : Umbilical catheter 5Fr – L.40cm – PUR (double lumen - 7ml/min / 9ml/min)

Device Class : 2

Duns Number: 392994778

Premarket Exempt : No

Product Code : FOS

Prescription Use : Yes

Device Count : 1

VYGON - 03660812130332 Catalog Number : 00088111

Device Description : Vyconnector - Straight double taper connector and adaptor - ØExt. 10.0-13.0mm / Vyconnector - Straight double taper connector and adaptor - ØExt. 10.0-13.0mm / 10.0-13.0mm

Device Class :

Duns Number: 392994778

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

VYGON - 03660812130899 Catalog Number : 1274.14

Device Description : Umbilical catheter 4Fr – L.20cm – PUR (double lumen - 11ml/min / 12ml/min)

Device Class :

Duns Number: 392994778

Premarket Exempt : No

Product Code : FOS

Prescription Use : Yes

Device Count : 1

VYGON - 03660812130905 Catalog Number : 1270.05

Device Description : Umbilical catheter 5Fr – L.40cm – 23ml/min – PUR

Device Class : 2

Duns Number: 392994778

Premarket Exempt : No

Product Code : FOS

Prescription Use : Yes

Device Count : 1

VYGON - 03660812131278 Catalog Number : 00053505

Device Description : Control suction catheter - Ø1.7mm - 05Fr - L.290mm

Device Class : 1

Duns Number: 392994778

Premarket Exempt : No

Product Code : BSY

Prescription Use : Yes

Device Count : 1

VYGON - 03660812134538 Catalog Number : 00088177

Device Description : Vyconnector - ØExt. 7.0-9.5mm / 7.0-9.5mm

Device Class : 1

Duns Number: 392994778

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : Yes

Device Count : 1

VYGON - 03660812136532 Catalog Number : 00087620

Device Description : Vycliccolor

Device Class : 2

Duns Number: 392994778

Premarket Exempt : No

Product Code : DTL

Prescription Use : Yes

Device Count : 1

VYGON - 03660812136686 Catalog Number : 1363.1421

Device Description : Nutrisafe2 - Feeding tube, closed tip, with stylet - 14Fr - L.75cm - PUR

Device Class :

Duns Number: 392994778

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

VYGON - 03660812137003 Catalog Number : 1362.0821

Device Description : Nutrisafe2 - Feeding tube, closed tip, with stylet - 08Fr - L.125cm - PUR

Device Class :

Duns Number: 392994778

Premarket Exempt : No

Product Code : FPD

Prescription Use : Yes

Device Count : 1

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