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Vygon

FDA UDI

Class II (US FDA UDI)

by Vygon Corp.

Identity

Trade Name
VYGON FDA UDI
Generic Name
In-line CPAP set, non-nebulizing FDA UDI
Device Name
BOUSSIGNAC CPAP SYSTEM - Adult M SIZE 5 FDA UDI
Model / Reference
5562.513 FDA UDI
Description
BOUSSIGNAC CPAP SYSTEM - Adult M SIZE 5 FDA UDI

Identifiers

Catalog Number
5562.513 FDA UDI
Primary DI / UDI-DI
08498840000458 FDA UDI
510(k) Number
K013884 FDA UDI
FDA Product Code
BYE FDA UDI
GMDN Term
In-line CPAP set, non-nebulizing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5965 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: In-line CPAP set, non-nebulizing

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

Similar devices

Also classified as In-line CPAP set, non-nebulizing.

Cleared under the same submission

K013884 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 de709f8a-d59a-4c6e-94c9-337046908565 35 fields · synced May 30, 2026