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510(k) Data Aggregation

    K Number
    K100366
    Device Name
    MEDICINA ENTERAL FEEDING TUBES AND ACCESSORIES MODEL MGX/YY
    Manufacturer
    Date Cleared
    2010-06-14

    (122 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MAXTER CATHETERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDICINA enteral feeding tubes and their accessories are dedicated to the nasogastric and orogastric administration of liquid nutritional media, through the gastro intestinal tract of neonatal and pediatric patients.
    Device Description
    MEDICINA feeding tubes is a complete range of devices intended to the gastro-intestinal feeding of patients, with liquid nutritional media. These feeding tubes are available in several sizes (diameter and length), and two materials: PolyUrethan (PUR) and silicon (SIL). They are equipped with connecting elements that does not incorporate a Luer, and thus eliminates the risk of inadvertently connecting the system to an Intra Veinous system. The MEDICINA feeding tube features a locking connection which eliminates the risk of involuntary disconnection; voluntary disconnection is achieved by simply unscrewing the hub connections. Another benefit of the MEDICINA system is that it does not change the technique of the end-user, and therefore it does not require any special training
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