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510(k) Data Aggregation

    K Number
    K172335
    Device Name
    Bleep DreamPort
    Manufacturer
    Date Cleared
    2018-03-30

    (240 days)

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

    snapCPAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bleep™ DreamPort nasal adhesive mask is intended to provide an interface from a Continuous Positive Airway Pressure (CPAP) or bi-level system. The mask to be used by adult patients (>66 lbs. / 30 kg, for whom positive airway pressure has been prescribed. The mask is for single-patient reuse in the home, hospital/institutional environment.
    Device Description
    The Bleep™ DreamPort nasal adhesive mask is similar to standard nasal pillow CPAP mask for use with patients using CPAP and bi-level equipment for the treat of OSA. The Bleep™ DreamPort nasal adhesive mask is comprised of 2 sub-assemblies: Nasal Port assembly and Airflow management assembly. The device uses single use foam tape to create the seal at the nostrils. This allows the interface to be used without head gear. There is a reusable interface which connects the nasal adhesive to the circuit of the CPAP equipment. It includes integrated exhalation ports.
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