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510(k) Data Aggregation

    K Number
    K150304
    Device Name
    Oxyless Blood Tubing Set
    Manufacturer
    Oxyless Ltd
    Date Cleared
    2016-02-24

    (383 days)

    Product Code
    FJK
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oxyless Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxyless Blood Tubing set with transducer protector and optional priming set comprises disposable blood tubing lines intended to provide extracorporeal access to the patient's blood during hemodialysis. This blood tubing set is indicated for use with a medically prescribed hemodialyzer. The compatibility of available configurations is the responsibility of the physician in charge.
    Device Description
    The Oxyless Blood Tubing Set is a hemodialysis blood tubing set designed to transport blood from a patient for acute or chronic hemodialysis treatment from the point of access to the dialyzer fixed to the hemodialysis machine and returning to the patient to complete the extracorporeal circuit. The tubing line components are preconfigured and packaged as an arterial line, a venous line and in some configurations, a priming line, for use with various dialysis machines from Fresenius, Nikkiso, B. Braun and Gambro. The components of the Oxyless Blood Tubing Set include pump tubing, air trap chambers, pressure monitoring lines, injection ports, service lines and tubing clamps. Major materials used for the various components of the Oxyless Blood Tubing Set are polyvinyl chloride (PVC), polycarbonate (PC), polypropylene (PP), polytetrafluoroethylene (PTFE) and silicone. The device is DEHP-free. Each Oxyless Blood Tubing Set is packaged as sterile and for single use only. It is for prescription use only on the order of a healthcare professional.
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