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Vygon

FDA UDI

Class II (US FDA UDI)

by VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG

Identity

Trade Name
VYGON FDA UDI
Generic Name
Centrally-inserted central venous catheter FDA UDI
Device Name
Leaderflex 22G 0,5x0,7mmx200mm FDA UDI
Model / Reference
1212.20 FDA UDI
Description
Leaderflex 22G 0,5x0,7mmx200mm FDA UDI

Identifiers

Catalog Number
1212.20 FDA UDI
Primary DI / UDI-DI
03660812011310 FDA UDI
FDA Product Code
FOZ FDA UDI
GMDN Term
Centrally-inserted central venous catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Centrally-inserted central venous catheter

Vygon by VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Centrally-inserted central venous catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
VYGON-Erzeugnisse für Medizin und Chirurgie-GmbH und Co. KG

Sources (1)

  • FDA UDI f66078fe-3194-4e89-9705-63db94c6c662 35 fields · synced May 30, 2026