Identity
- Trade Name
- VYGON FDA UDI
- Generic Name
- In-line CPAP pressure generating chamber FDA UDI
- Device Name
- CPAP Boussignac with connection line FDA UDI
- Model / Reference
- 5570.13 FDA UDI
- Description
- CPAP Boussignac with connection line FDA UDI
Identifiers
- Catalog Number
- 5570.13 FDA UDI
- Primary DI / UDI-DI
- 03660812115865 FDA UDI
- 510(k) Number
- K013884 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- In-line CPAP pressure generating chamber 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
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: In-line CPAP pressure generating chamber
Vygon by Vygon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as In-line CPAP pressure generating chamber.
- VYGON — Vygon Corp. · Class II
Cleared under the same submission
K013884 also covers:
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 9a982f11-d131-48a4-9a48-eec44e0a67ec 36 fields · synced Jun 6, 2026