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Premicath

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
Premicath FDA UDI
Generic Name
Peripherally-inserted central venous catheter FDA UDI
Device Name
PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND 24 G CANNULA FDA UDI
Model / Reference
1261.207G FDA UDI
Description
PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND 24 G CANNULA FDA UDI

Identifiers

Catalog Number
1261.207G FDA UDI
Primary DI / UDI-DI
08498840008492 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 24 Millimeter FDA UDI

Category: Peripherally-inserted central venous catheter

Premicath 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.

Cleared under the same submission

K041468 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 d6f08e5d-4798-4b99-8391-2af43212f1a0 37 fields · synced May 30, 2026