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    K Number
    K252173
    Device Name
    F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full
    Manufacturer
    Fisher & Paykel Healthcare Ltd
    Date Cleared
    2025-09-10

    (61 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K191624,K203449
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Fisher & Paykel Healthcare single-patient use masks are intended for use as an accessory to ventilators to enable non-invasive positive pressure ventilation (NPPV) therapy (CPAP or bi-level) to be delivered to spontaneously breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure who have been prescribed NPPV. The masks are to be fitted and therapy maintained, by trained medical practitioners in a hospital/institutional environment with patient monitoring in place.

    Device Description

    The F&P OptiNIV Vented Full Face Masks are oro-nasal full face masks that are intended for use as an accessory to deliver non-invasive positive pressure ventilation (NPPV) to a patient as part of a non-invasive ventilation system.

    The OptiNIV Vented Full Face Masks are prescription-only, provided in a non-sterile state.

    The F&P OptiNIV Vented Full Face Mask consists of a plastic shell with a seal to allow cushioning onto the patient's face, and straps to enable the mask to be secured over the head. The mask fits under the patient's nose and covers the nares of the nose and the mouth, with a soft seal to maintain pressure inside the mask whilst minimizing discomfort to the user.

    The subject device is available in three sizes – A, B, and C to denote the seal sizes.

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