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Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
VYGON FDA UDI
Generic Name
Centrally-inserted central venous catheter FDA UDI
Device Name
4FR X 20CM SINGLE LUMEN CT MIDLINE FDA UDI
Model / Reference
VYML4S0001 FDA UDI
Description
4FR X 20CM SINGLE LUMEN CT MIDLINE FDA UDI

Identifiers

Catalog Number
VYML4S0001 FDA UDI
Primary DI / UDI-DI
00849884000962 FDA UDI
510(k) Number
K181208 FDA UDI
FDA Product Code
PND 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Category: Centrally-inserted central venous catheter

Vygon by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Centrally-inserted central venous catheter.

Cleared under the same submission

K181208 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vygon Corp.

Sources (1)

  • FDA UDI 431757f5-628c-424d-8f79-21eed1067f0f 35 fields · synced May 31, 2026