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510(k) Data Aggregation

    K Number
    K073363
    Device Name
    THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
    Manufacturer
    PALADIN BIOMEDICAL CORPORATION
    Date Cleared
    2008-03-20

    (111 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    PALADIN BIOMEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Paladin Biomedical Corporation ThermoStat 900 Administration Set is intended to be used with the MMS Thermostat 900 Blood and Fluid Warmer. The disposable cartridge and administration set is intended to deliver high volume, rapid administration of blood and physiological fluids when connected to a large bore catheter. The set is intended to help prevent hypothermia in patients receiving large volumes of fluids.
    Device Description
    There are two configurations of the administration set the ASH200 (High flow - 2 spike) and ASH300 (high flow - 3 spike). Materials of construction are all known biocompatible materials. The set consists of three major sub assemblies: - tubing and administration set consisting of tubing, spikes, clamps, luers, . drip chambers - filter/vent assembly . - cartridge assembly. .
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