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510(k) Data Aggregation

    K Number
    K121736
    Device Name
    PERF-GEN PULSATILE PERFUSION SOLUTION
    Manufacturer
    WATERS MEDICAL SYSTEMS, LLC
    Date Cleared
    2013-08-16

    (429 days)

    Product Code
    KDL
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PERF-GEN® Pulsatile Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
    Device Description
    The PERF-GEN® Pulsatile Perfusion (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 mEq/L, and a pH of approximately 7.4 at room temperature.
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    K Number
    K121618
    Device Name
    BEL-GEN COLD STORAGE SOLUTION
    Manufacturer
    WATERS MEDICAL SYSTEMS, LLC
    Date Cleared
    2013-06-14

    (378 days)

    Product Code
    KDL, KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEL-GEN® Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
    Device Description
    The BEL-GEN® Cold Storage Solution (BEL-GEN Solution) is clear to light yellow, sterile and pyrogen-free solution. BEL-GEN Solution has an approximate osmolality of 320 mOsm/kg, a sodium concentration of 29 mmol/L, a potassium concentration of 125 mmol/L and a pH of 7.4 at 20°C.
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    K Number
    K111521
    Device Name
    WAVES
    Manufacturer
    WATERS MEDICAL SYSTEMS, LLC
    Date Cleared
    2012-02-16

    (260 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    WATERS MEDICAL SYSTEMS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.
    Device Description
    The WAVES is a transportable, self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The WAVES system provides controlled pulsatile kidney perfusion using oxygenated hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The WA VES system can be configured to signal an audio and visual alarm for user-selected limits. The WAVES is a two-part system comprising a 'control unit' for perfusion and monitoring of a single kidney, and a sterile, single-use, disposable 'cassette module' used to contain, refrigerate, and circulate perfusate to and through the kidney.
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