Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Ve…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190254 FDA 510(k)
- FDA Product Code
- BZD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are respiratory masks designed for use with CPAP and NIV therapy. These masks feature a lightweight design with adjustable four-point headgear to provide a personalized, comfortable fit during patient therapy, accommodating for changes in weight and facial asymmetry.
The masks are intended for use with ventilators and are classified as non-continuous respirators. They are supplied in various sizes and are authorized under FDA 510K clearance with product code BZD. The masks are designed for single-patient use and are not specified as MRI safe.
Frequently asked questions
What are the Mojo 2, Veraseal 3, and V3 Full Face Vented Masks used for?
These respiratory masks are designed for use with CPAP and NIV therapy. They feature a lightweight design with adjustable four-point headgear to provide a personalized, comfortable fit during patient therapy, accommodating for changes in weight and facial asymmetry.
Are these masks reusable or single-use?
The masks are designed for single-patient use, meaning they should be used by one patient only and not shared among multiple patients. This helps maintain hygiene and ensures proper therapy delivery.
What sizes are available for these masks?
The Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are supplied in various sizes to accommodate different facial structures and patient needs. The specific size options should be confirmed with the manufacturer or product documentation.
Are these masks MRI safe?
The masks are not specified as MRI safe in the provided information. Patients requiring MRI should consult with their healthcare provider about appropriate respiratory equipment options that are compatible with MRI environments.
What is the regulatory status of these masks?
These masks are authorized under FDA 510K clearance with product code BZD. They are classified as non-continuous respirators and are intended for use with ventilators. The FDA clearance indicates they are substantially equivalent to predicate devices on the market.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sleepnet Mojo®2 Full Face Mask - Respiratory masks for CPAP and NIV, Sleepnet Mojo® Full Face Mask - for CPAP or NIV interfaces, Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190254 | Class II | Active |
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Manufacturer
- Manufacturer
- Sleepnet Corporation
Sources (1)
- FDA 510(k) K190254 24 fields · synced Sep 28, 2026