Identity
- Trade Name
- Somnics FDA UDI
- Generic Name
- Intraoral negative-pressure sleep apnoea unit FDA UDI
- Device Name
- iBreath Breathing Training Kit FDA UDI
- Model / Reference
- iBreath FDA UDI
- Description
- iBreath Breathing Training Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719878320856 FDA UDI
- FDA Product Code
- OZR FDA UDI
- GMDN Term
- Intraoral negative-pressure sleep apnoea unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intraoral negative-pressure sleep apnoea unit
Somnics by Somnics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- iNAP — SOMNICS, INC. · Class II
- iNAP — SOMNICS, INC. · Class II
- iNAP One — SOMNICS, INC. · Class II
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
- Somnics, Inc.
Sources (1)
- FDA UDI b2ea793c-d48f-4b38-b971-4a182d34d081 34 fields · synced Jun 6, 2026