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510(k) Data Aggregation

    K Number
    K170722
    Device Name
    Moxxly Flow Collection System
    Manufacturer
    Date Cleared
    2017-08-28

    (172 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moxxly, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Moxxly Flow breast pump collection system is intended to be used in conjunction with a compatible powered breast pump for the purpose of expressing human milk
    Device Description
    Moxxly, Inc. is the manufacturer of the Moxxly Flow, a device intended to be used in conjunction with a compatible breast pump for the purpose of expressing human milk. The Moxxly Flow consists of two collection units designed to be compatible with select compatible electric breast pumps and provide a more comfortable design to aid collection of breast milk. The Moxxly Flow is provided non-sterile and is a single patient reusable device. The system should be cleaned by the user prior to use. The device has a sloped flange (cup insert), flexible neck, internal valve assembly and low-profile bottle. Variations of the device incorporate minor differences to replicate the functional and performance characteristics necessary for use with additional pump brands. The Moxxly device is designed to fit within a lactating woman's ordinary or nursing bra and held in place there while breast pumping. When the pump extracts milk, the milk flows out through the end of the flange, where it passes through the neck and valve system at the bottom of the bra and into the attached collection bottle. When the lactating woman is done pumping, she turns off the pump, removes the Moxxly device from under her clothes and transfers the milk to a storage container for later use.
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