Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name: VYGON FDA UDI
Generic Name: General specimen collection kit FDA UDI
Device Name: Neosump - Gastric aspirator - Ø3,3 mm - 10Fr - 900 mm FDA UDI
Model / Reference: 5382.10 FDA UDI
Description: Neosump - Gastric aspirator - Ø3,3 mm - 10Fr - 900 mm FDA UDI

Identifiers

Catalog Number: 00538210 FDA UDI
Primary DI / UDI-DI: 03660812139908 FDA UDI
FDA Product Code: KNT FDA UDI
GMDN Term: General specimen collection kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 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: General specimen collection kit

Vygon by Vygon Corp. — Class II — 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 II	Pending data

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Manufacturer

Manufacturer: Vygon Corp.

Sources (1)

FDA UDI c4f26cee-6611-42eb-91f1-416101cfd6ef 35 fields · synced May 31, 2026