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510(k) Data Aggregation

    K Number
    K112271
    Device Name
    3B WILLOW
    Manufacturer
    3B PRODUCTS, LLC
    Date Cleared
    2012-02-16

    (192 days)

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

    3B PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Willow™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device or a bilevel system The Willow ™ is: (1) to be used by adult patients (> 66lb / 30 kg) for the treatment of sleep disordered breathing, such as obstructive sleep apnea (OSA), for whom positive airway pressure has been prescribed. (2) to be used for single-patient reuse in the home environment.
    Device Description
    The 3B Willow™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. The 3B WillowTM is a prescription device supplied non-sterile.
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    K Number
    K103434
    Device Name
    3B FLEX-LITE
    Manufacturer
    3B PRODUCTS, LLC
    Date Cleared
    2011-10-13

    (324 days)

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

    3B PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3B Flex-Lite™ channels airflow noninvasively to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or a bilevel system. The 3B Flex-Lite™ is: - to be used by adult patients (>66lb / 30 kg); (1) - to be used for single-patient reuse in the home environment and multipatient (2) reuse in the hospital/institutional environment. - (3) to be used in the following environments: home, hospital, and sub-acute institutions. - intended for prescription use. (4)
    Device Description
    The 3B Flex-Lite™ is a mask interface, of the nasal pillow variety, that directs airflow from a positive pressure device to the patient's nose. The mask is held in place with adjustable headgear that straps the mask to the face. The 3B Flex-Lite™ is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. The 3B Flex-Lite™ is a prescription device supplied non-sterile.
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