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510(k) Data Aggregation

    K Number
    K163464
    Device Name
    Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)
    Manufacturer
    Date Cleared
    2017-09-05

    (270 days)

    Product Code
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    BMC MEDICAL.,LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Viva Nasal Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Viva Nasal Mask is: []To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed. □Intended for single-patient reuse. The Numa Full Face Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or Bi-level system. The Numa Full Face Mask is: □ To be used by adult patients (>661bs />30kg) for whom positive airway pressure has been prescribed. □ Intended for single-patient reuse.
    Device Description
    Viva Nasal Mask provides an interface such that airflow from a positive pressure source is directed to the patient's nose. The masks are held in place with adjustable headgear that straps the mask to the face. Viva Nasal Mask has plastic body and silicone seal that touches the face and includes a pad that rests on the forehead. The Viva Nasal Mask is a prescription device supplied non-sterile. Numa Full Face Mask provides an interface such that airflow from a positive pressure source is directed to the patient's mouth and nose. The masks are held in place with adjustable headgear that straps the mask to the face. Numa Full Face Mask has plastic body and silicone seal that touches the face and include an adjustable pad that rests on the forehead. Numa Full Face Mask is a prescription device supplied non-sterile.
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