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510(k) Data Aggregation

    K Number
    K130379
    Device Name
    ROLLINS 7 OXYGEN MASK
    Date Cleared
    2013-10-09

    (237 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLLINS MEDICAL SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rollins 7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
    Device Description
    The Rollins 7 Oxygen Mask consists of the following features: 1) mask, 2) strap holes, 3) swivel, 4) oxygen inlet, 5)oxygen inlet cap, 6) oxygen outlet diverter, 7) adapter body, 8) fenestration opening slits on both sides of the mask, 9) opening at the chin area, 10) MDI (metered dose inhaler) port hole inlet and insert locks in place, 11) adapter inlet bottom cap, 12) nebulizer inlet, 13) oxygen tubing, 14) oxygen mask inlet for connecting the adapter, and 15) design nipples (left and right) 16) oxygen tubing with one end universal connector and the other end standard oxygen connector 17) oxygen flow rate to FiO2 label attached to universal connector end.
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