Identity
- Trade Name
- Breeze FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- The Breeze Nasal + Mask is designed for nasal ventilation via the use of a barometric device delivering Continuous Positive Airway Pressure (CPAP) or bi-level pressure (BiPAP). FDA UDI
- Model / Reference
- Breeze Nasal+ M FDA UDI
- Description
- The Breeze Nasal + Mask is designed for nasal ventilation via the use of a barometric device delivering Continuous Positive Airway Pressure (CPAP) or bi-level pressure (BiPAP). FDA UDI
Identifiers
- Catalog Number
- M-268030-11 FDA UDI
- Primary DI / UDI-DI
- 03700659400691 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CPAP/BPAP nasal mask, single-use
Breeze by Sefam — 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
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
- Sefam
Sources (1)
- FDA UDI 49abbf49-db85-4694-bc9f-35c4686b1ee0 34 fields · synced Jun 8, 2026