Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name: VYGON FDA UDI
Generic Name: Vial/bottle adaptor, non-hermetic FDA UDI
Device Name: No-needle vial access cap with Bionector FDA UDI
Model / Reference: 821.21 FDA UDI
Description: No-needle vial access cap with Bionector FDA UDI

Identifiers

Catalog Number: 821.21 FDA UDI
Primary DI / UDI-DI: 03660812008792 FDA UDI
FDA Product Code: FPD FDA UDI
GMDN Term: Vial/bottle adaptor, non-hermetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vial/bottle adaptor, non-hermetic

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

Similar devices

Also classified as Vial/bottle adaptor, non-hermetic.

ICU Medical — ICU MEDICAL, INC. · Class II
ICU Medical — ICU MEDICAL, INC. · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
Vial Adapter — WEST PHARMA. SERVICES IL, . LTD · Class II
Vial Adapter — WEST PHARMA. SERVICES IL, . LTD · Class II
Mini-Spike® — B. BRAUN MEDICAL INC. · Class II
ViaLok — Yukon Medical, LLC · Class II
ICU Medical — ICU MEDICAL, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Vygon Corp.

Sources (1)

FDA UDI fe8704c7-4306-42dd-8155-31295dcbdb74 35 fields · synced May 30, 2026