Identity
- Trade Name
- Somnera Nasal Mask FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- Somnera Nasal Mask for use with the Somnera Positive Airway Pressure System FDA UDI
- Model / Reference
- M1 (L) FDA UDI
- Description
- Somnera Nasal Mask for use with the Somnera Positive Airway Pressure System FDA UDI
Identifiers
- Catalog Number
- 79648 FDA UDI
- Primary DI / UDI-DI
- 30810045450101 FDA UDI
- 510(k) Number
- K200698 FDA UDI
- FDA Product Code
- QBY FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5273 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP nasal mask, single-use
Somnera Nasal Mask by Fresca Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP nasal mask, single-use.
- BiTrac Vented — Pulmodyne Inc. · Class II
- PN841 — Respironics, Inc. · Class II
- Flow-Safe II Disposable CPAP System — MERCURY ENTERPRISES, INC. · Class II
- PN841 — Respironics, Inc. · Class II
- BiTrac HC — Pulmodyne Inc. · Class II
- FitStar Hospital Nasal Non Vented Mask, s/m — Sleepnet Corporation · Class II
- Whisper Soft — Engineered Medical Systems, LLC · Class II
- BiTrac — Pulmodyne Inc. · Class II
Cleared under the same submission
K200698 also covers:
- Somnera Airbox Air Filter Pack — FRESCA MEDICAL, INC.
- Somnera Backstrap — FRESCA MEDICAL, INC.
- Somnera Headgear — FRESCA MEDICAL, INC.
- Somnera Hose — FRESCA MEDICAL, INC.
- Somnera Nasa Mask — FRESCA MEDICAL, INC.
- Somnera Nasal Mask — FRESCA MEDICAL, INC.
- Somnera Nasal Mask Fit Kit — FRESCA MEDICAL, INC.
- Somnera Nasal Pillow Fit Kit — FRESCA MEDICAL, INC.
- Somnera Pillow — FRESCA MEDICAL, INC.
- Somnera Pillow — FRESCA MEDICAL, INC.
- Somnera Pillow — FRESCA MEDICAL, INC.
- Somnera System Nasal Mask — FRESCA MEDICAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fresca Medical, Inc.
Sources (1)
- FDA UDI 51cd4cfc-7b8e-4bad-8d14-f0c7175ed692 37 fields · synced Jun 8, 2026