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510(k) Data Aggregation

    K Number
    K060316
    Device Name
    COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS
    Manufacturer
    FRESENIUS KABI DEUTSCHLAND GMBH
    Date Cleared
    2006-06-23

    (135 days)

    Product Code
    LZH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRESENIUS KABI DEUTSCHLAND GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Compat GOTM feeding pump with the administration sets are intended exclusively for enteral feeding. The purpose of this administration system is the delivery of Enteral nutrition at controlled rates (pump assisted) to patients gastrointestinal system. Intended for us for patient with any condition requiring Enteral feeding and Enteral hydration. The Compat GOTM Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets are intended to use by adults or paediatric in hospital and home care environments, both in stationary and ambulatory ways.
    Device Description
    The Compat GOTM Enteral Feeding Pump ( a Class II device) and Enteral Administration Sets are designed to deliver formulas and Enteral hydration liquids via linear peristaltic pumping to provide nutrition for patients which are not able to ingest food orally. The Compat GOTM Enteral Feeding_System is working with the Compat GO™ Enteral Feeding Pump and the Compat GOTM Enteral Administration Sets only caused by its adapted safety and effectiveness concept. The Compat GOTM Enteral Administration Sets are compatible with the standard prefilled formula containers presently available on the market. The Compat GO™ Enteral Administration Sets are designed to compatible with present market Enteral access devices and accessories.
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