Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163464 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 Viva Nasal Mask (Model: NM4) and Numa Full Face Mask (Model: BMC-FM2) are patient interfaces for positive airway pressure (CPAP/bi-level) therapy, classified as ventilators, non-continuous (respirators). These devices deliver airflow to a patient’s nose (NM4) or nose and mouth (BMC-FM2) via a plastic body, silicone seal, and adjustable headgear. They are designed to facilitate respiratory support in controlled breathing applications.
These masks are intended for use in home environments by adult patients and connect to a 22mm entrainment valve elbow for circuit attachment. They are supplied as single-use devices, with no indication of MRI compatibility. The devices hold FDA 510(k) clearance under product code BZD, classified as Class II under special controls. Storage and handling instructions are not specified in the provided data.
Frequently asked questions
What are the Viva Nasal Mask (NM4) and Numa Full Face Mask (BMC-FM2) used for?
These devices are patient interfaces for positive airway pressure (CPAP/bi-level) therapy, classified as ventilators for non-continuous (respirator) applications. The Viva Nasal Mask (NM4) delivers airflow to a patient’s nose, while the Numa Full Face Mask (BMC-FM2) covers both nose and mouth. They are designed to provide respiratory support in controlled breathing environments, such as home settings for adult patients.
How are these masks supplied and intended for use?
Both the Viva Nasal Mask (NM4) and Numa Full Face Mask (BMC-FM2) are supplied as single-use devices. They are intended for use in home environments by adult patients and connect to a 22mm entrainment valve elbow for attachment to a CPAP or bi-level machine. This setup ensures a secure and sterile connection for each use.
Are these masks reusable or sterile upon packaging?
The Viva Nasal Mask (NM4) and Numa Full Face Mask (BMC-FM2) are explicitly labeled as single-use devices. This means they are intended for one-time use only and are not designed for reuse. Sterility is maintained through single-use packaging, eliminating the need for reprocessing or cleaning between patients.
What materials are used in the construction of these masks?
The devices feature a plastic body and a silicone seal, which provide a comfortable and secure fit for the patient. The adjustable headgear ensures proper positioning and stability during use. The silicone seal is particularly important for creating an effective seal to prevent air leaks during therapy.
Are there any special storage instructions for these masks?
The provided data does not specify detailed storage instructions for the Viva Nasal Mask (NM4) or Numa Full Face Mask (BMC-FM2). However, as single-use devices, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow general medical device storage guidelines to maintain their integrity until use.
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: Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2 ..., K163464 FDA 510 (k) - Viva Nasal Mask (Model: NM4), Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) by ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163464 | Class II | Active |
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Manufacturer
- Manufacturer
- Bmc Medical., Ltd.
Sources (1)
- FDA 510(k) K163464 24 fields · synced Oct 1, 2026