Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name: VYGON FDA UDI
Generic Name: Vascular port administration set FDA UDI
Device Name: 10" WINGED SAFETY INFUSION SET WITH 19 GA. X 1" HUBER NEEDLE FDA UDI
Model / Reference: SHS-1910 FDA UDI
Description: 10" WINGED SAFETY INFUSION SET WITH 19 GA. X 1" HUBER NEEDLE FDA UDI

Identifiers

Catalog Number: SHS-1910 FDA UDI
Primary DI / UDI-DI: 08498840007167 FDA UDI
510(k) Number: K020544 FDA UDI
FDA Product Code: FPA FDA UDI
GMDN Term: Vascular port administration 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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: Vascular port administration set

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

Similar devices

Also classified as Vascular port administration set.

Port Access Needle — Bard Access Systems, Inc. · Class II
Port Access Needle — Bard Access Systems, Inc. · Class II
PowerLoc — Bard Access Systems, Inc. · Class II
Port Access Kit — Bard Access Systems, Inc. · Class II
PORT ACCESS INFUSION SET — SB-KAWASUMI LABORATORIES, INC. · Class II
Port Access Kit — Bard Access Systems, Inc. · Class II
Infusion Safety Products, Inc. — Infusion Safety Products, Inc. · Class II
Infusion Safety Products, Inc. — Infusion Safety Products, Inc. · Class II

Cleared under the same submission

K020544 also covers:

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

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Manufacturer

Manufacturer: Vygon Corp.

Sources (1)

FDA UDI ca630272-2e44-4e74-901a-6987b5f4f8b2 35 fields · synced May 30, 2026