Vygon

FDA UDI

Class I (US FDA UDI)

by Vygon Corp.

Identity

Trade Name: VYGON FDA UDI
Generic Name: Pleural catheter FDA UDI
Device Name: Trocar drain for pleural drainage of newborn - Ø2.5mm (08F) - L.8cm FDA UDI
Model / Reference: 625.08 FDA UDI
Description: Trocar drain for pleural drainage of newborn - Ø2.5mm (08F) - L.8cm FDA UDI

Identifiers

Catalog Number: 00062508 FDA UDI
Primary DI / UDI-DI: 03660812007740 FDA UDI
FDA Product Code: KDD FDA UDI
GMDN Term: Pleural catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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: Pleural catheter

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

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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 I	Pending data

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Manufacturer

Manufacturer: Vygon Corp.

Sources (1)

FDA UDI c5129806-4f02-4335-8422-a8aa02a637f7 35 fields · synced May 30, 2026