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Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
VYGON FDA UDI
Generic Name
Intravenous administration tubing extension set FDA UDI
Device Name
30" STANDARDBORE EXTENSION SET WITH ROTATING MALE LUER LOCK, FEMALE LUER LOCK AND PINCH CLAMP FDA UDI
Model / Reference
AMS-385 FDA UDI
Description
30" STANDARDBORE EXTENSION SET WITH ROTATING MALE LUER LOCK, FEMALE LUER LOCK AND PINCH CLAMP FDA UDI

Identifiers

Catalog Number
AMS-385 FDA UDI
Primary DI / UDI-DI
08498840012635 FDA UDI
510(k) Number
K101368 FDA UDI
FDA Product Code
FPA FDA UDI
GMDN Term
Intravenous administration tubing extension set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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: Intravenous administration tubing extension set

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

Similar devices

Also classified as Intravenous administration tubing extension set.

Cleared under the same submission

K101368 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 cdcffc44-d782-42f4-8b6c-2f9e644f7e87 35 fields · synced May 30, 2026