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510(k) Data Aggregation

    K Number
    K151503
    Device Name
    NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
    Date Cleared
    2016-04-05

    (306 days)

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

    GBUK Enteral Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.
    Device Description
    The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is an enteral feeding tube designed for continuous or intermittent use. It comprises of radio-opaque polyurethane tube with guide wire set and ENFit connector. The guide wire set is composed of a rigid guide wire and a male threaded connector, which is inserted into the polyurethane tube. They're depth marks printed on the tube in order to provide reference about the depth of insertion to the practitioner. The tube is to be inserted through the nasal or oral area and feed down into the alimentary canal system (i.e. stomach area, duodenum or small intestine as intended). The guide wire with male connector is removed when the insertion is done leaving the tube and ENFit connector in situ. Only a female ENFit enteral syringe can be attached to the ENFit connector when in use.
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