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Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
VYGON FDA UDI
Generic Name
Arterial blood pressure catheter FDA UDI
Device Name
Arterial Leadercath (PE) FDA UDI
Model / Reference
115.11 FDA UDI
Description
Arterial Leadercath (PE) FDA UDI

Identifiers

Catalog Number
115.11 FDA UDI
Primary DI / UDI-DI
03660812000420 FDA UDI
FDA Product Code
DQO FDA UDI
GMDN Term
Arterial blood pressure catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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: Arterial blood pressure catheter

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

Similar devices

Also classified as Arterial blood pressure catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vygon Corp.

Sources (1)

  • FDA UDI d4a9f88d-022a-4617-9381-8b6de446e43a 35 fields · synced May 30, 2026