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510(k) Data Aggregation

    K Number
    K120443
    Device Name
    NEUTRAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH NEUTRAL LUER ACTIVATED DEVICE
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
    Date Cleared
    2012-05-22

    (98 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.
    Device Description
    The Neutral Luer Activated Device (LAD) and Extension Sets with Neutral Luer Activated Device are single use disposable devices intended for use with a vascular access device for continuous or intermittent fluid administration or withdrawal of fluids. The device is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path and is designed to be easy to swab. A saline flush of 10 mL is able to clear the Neutral LAD of blood after sampling blood through the device. The Neutral LAD is clear and allows the clinician to view the fluid path of the device. The Neutral LAD has a low priming volume (0.08 mL) that allows medication to be flushed from the device with small amounts of fluid and is the maximum amount of medication that could potentially remain in the device when administered to a patient prior to flushing. A LAD with a low priming/residual volume is favored for pediatric patients or patients requiring fluid restriction. The device is a neutral fluid displacement LAD and does not require a specific clamping sequence in order to be used safely. This neutral displacement design has the added benefit of helping to reduce the occurrence of thrombotic catheter occlusions by limiting the reflux of blood into the catheter. The Neutral LAD may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.
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    K Number
    K093120
    Device Name
    XENIUM XPM 110, XENIUM XPM 130, MODELS M25649A, M25650A, XENIUM XPM 150, XENIUM XPM 170
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
    Date Cleared
    2010-02-17

    (138 days)

    Product Code
    KDI
    Regulation Number
    876.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemodialysis with Xenium XPM dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
    Device Description
    Xenium XPM dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which are differentiated by membrane surface area.
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