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Vygon

FDA UDI

Class I (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
VYGON FDA UDI
Generic Name
Oxygen therapy conserving regulator FDA UDI
Device Name
Angled FiO2 adapter for CPAP Boussignac FDA UDI
Model / Reference
5566.01 FDA UDI
Description
Angled FiO2 adapter for CPAP Boussignac FDA UDI

Identifiers

Catalog Number
00556601 FDA UDI
Primary DI / UDI-DI
03660812115841 FDA UDI
FDA Product Code
CAN FDA UDI
GMDN Term
Oxygen therapy conserving regulator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.2700 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oxygen therapy conserving regulator

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

Similar devices

Also classified as Oxygen therapy conserving regulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vygon Corp.

Sources (1)

  • FDA UDI eb47a9d4-995d-416d-b15d-a34d3f806097 35 fields · synced Jun 8, 2026