Identity
- Trade Name
- APEX FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Nasal Mask with Headgear (XS) FDA UDI
- Model / Reference
- WiZARD 210 FDA UDI
- Description
- Nasal Mask with Headgear (XS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04713025000547 FDA UDI
- 510(k) Number
- K103174 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, reusable 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: CPAP/BPAP nasal mask, reusable
The APEX nasal mask with headgear is a flexible, form-shaped device designed to provide direct ambient air or medical oxygen at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV) in patients requiring assisted breathing. Made of plastic and/or silicone materials that create an airtight seal around the nose, this reusable device is available in various designs and sizes. It features a headstrap to stabilize it and can be used as part of a CPAP or Bi-level Positive Airway Pressure (BPAP) unit.
Similar devices
Also classified as CPAP/BPAP nasal mask, reusable.
- DreamWear — Respironics, Inc. · Class II
- SWIFT FX — RESMED PTY LTD · Class II
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- Nasal-Aire — Innomed Technologies · Class II
- ComfortGel Blue — Respironics, Inc. · Class II
- Dream Wisp — Respironics, Inc. · Class II
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- DreamWear Gel Pillow — Respironics, Inc. · Class II
Cleared under the same submission
K103174 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Wellell Inc.
Sources (1)
- FDA UDI 34f43de1-640d-46e0-a172-2195a5c9fa49 34 fields · synced Jul 11, 2026