Ultra Mirage Ii Mask
FDA 510(k)Class II (US FDA 510(k))
by Resmed, Ltd.
Identifiers
- 510(k) Number
- K050359 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 Ultra Mirage II Nasal Mask is a nasal mask designed for use with ventilators, specifically for continuous positive airway pressure (CPAP) or bilevel therapy. Classified as a ventilator, non-continuous (respirator), it is intended for multipatient use in hospital, clinic, and home settings. The device incorporates dual-wall cushion technology and features an air vent design to enhance performance and comfort during therapy.
This mask is supplied for multipatient use and is regulated under FDA 510(k) clearance (K050359) with a classification of Class II. It is intended for adult patients and is designed to be compatible with ventilators equipped with an active exhalation valve. The device is not described as single-use or reusable in the specifications, and no specific sterility or MRI safety information is provided. Storage instructions are not detailed, but the mask is intended for use in clinical and home environments.
Frequently asked questions
What is the Ultra Mirage II Nasal Mask used for?
The Ultra Mirage II Nasal Mask is designed specifically for use with ventilators to provide continuous positive airway pressure (CPAP) or bilevel therapy. It is intended for adult patients and supports respiratory treatment in hospital, clinic, and home environments. The dual-wall cushion technology and air vent design enhance performance and patient comfort during therapy.
How is the Ultra Mirage II Nasal Mask supplied and intended for use?
This mask is supplied for multipatient use, meaning it is intended to be shared among multiple patients in clinical or home settings. It is not classified as single-use or reusable in the provided specifications, though proper cleaning and maintenance are implied for multipatient use. It is compatible with ventilators equipped with an active exhalation valve.
Is the Ultra Mirage II Nasal Mask sterile?
The provided specifications do not explicitly state whether the Ultra Mirage II Nasal Mask is sterile or require sterilization. For multipatient use, it is likely intended to be cleaned and disinfected between uses, but specific sterility instructions are not detailed in the data.
What sizes or models are available for the Ultra Mirage II Nasal Mask?
The specifications list multiple registration numbers (e.g., 3030970580, 3010440667) associated with the Ultra Mirage II Nasal Mask, which may correspond to different models or variations. These identifiers are used for regulatory tracking and do not directly indicate specific sizes or models. For precise size options, refer to the manufacturer’s product catalog or technical documentation.
How should the Ultra Mirage II Nasal Mask be stored?
The provided data does not include detailed storage instructions for the Ultra Mirage II Nasal Mask. However, as it is intended for multipatient use in clinical and home settings, it should be stored in a clean, dry environment to prevent contamination. Follow manufacturer guidelines for proper handling and maintenance to ensure optimal performance and hygiene.
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: PDF Ultra Mirage™ II Nasal Mask - ResMed, PDF Ultra Mirage II Nasal Mask - document.resmed.com, Ultra Mirage II Nasal CPAP Mask Kit By ResMed, Ultra Mirage NV hypoallergenic nasal mask | Resmed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050359 | Class II | Active |
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Manufacturer
- Manufacturer
- Resmed, Ltd.
Sources (1)
- FDA 510(k) K050359 24 fields · synced Oct 1, 2026