Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name: VYGON FDA UDI
Generic Name: Peripherally-inserted central venous catheter FDA UDI
Device Name: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE FDA UDI
Model / Reference: 1261.203A FDA UDI
Description: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLITTING NEEDLE FDA UDI

Identifiers

Catalog Number: 1261.203A FDA UDI
Primary DI / UDI-DI: 08498840011140 FDA UDI
510(k) Number: K041468 FDA UDI
FDA Product Code: LJS FDA UDI
GMDN Term: Peripherally-inserted central venous catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5970 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 24 Millimeter FDA UDI

Category: Peripherally-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 Peripherally-inserted central venous catheter.

BioFlo — NAVILYST MEDICAL, INC. · Class II
Synergy — Health Line International Corp · Class II
ARROW — TELEFLEX INCORPORATED · Class II
ARROW — TELEFLEX INCORPORATED · Class II
PowerPICC — Bard Access Systems, Inc. · Class II
ARROW — TELEFLEX INCORPORATED · Class II
PowerPICC Provena — Bard Access Systems, Inc. · Class II
BioFlo — NAVILYST MEDICAL, INC. · Class II

Cleared under the same submission

K041468 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 74ace936-9faa-4b34-951f-678f5de936e7 37 fields · synced May 30, 2026