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510(k) Data Aggregation

    K Number
    K043098
    Device Name
    GERBER DOUBLE ELECTRIC BREAST PUMP
    Date Cleared
    2004-12-15

    (36 days)

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

    GERBER PRODUCTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    An electrically powered breast pump with adjustable vacuum and massage settings and 2 funnels for expressing milk from the breasts of a lactating woman.
    Device Description
    The Gerber Double Electric Breast Pump is a simple and effective system for expressing milk from a lactating women's breast(s). The device includes the following components: a pump base, flexible tubing, a funnel assembly, a carrying bag, and accessories (e.g. bottles, nipples, and disposable nursing pads). The device is powered by a variable speed power supply that drives a diaphragm pump creates the negative pressure required to extract breast milk. The breast pump is capable of providing a variable vacuum and massage like motion. A maximum vacuum of 240 mm Hg can be applied to one or both breasts.
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