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510(k) Data Aggregation

    K Number
    K974387
    Device Name
    PDM3 DISINFECTION SYSTEM FOR PERITONEAL DIALYSIS EXCHANGES, PATIENT TRANSFER SET PTS102, CAP, HIGH TEMPERATURE
    Manufacturer
    MICROWAVE MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-09-01

    (649 days)

    Product Code
    KDJ
    Regulation Number
    876.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICROWAVE MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PDM3 is intended for use by Peritoneal Dialysis patients in moist-heat intraluminal disinfection of ONLY the MMS PTS102 Patient Transfer Set connector when mated with a Baxte UltraBag™ connector or with a MMS 190259 High Temperature Cap. The MMS PTS102 Transfer Set is intended for use by Peritoneal Dialysis Patients to connect between the patient's catheter and either: 1) a Baxter UltraBag™ dialysate solution bag connector during a Peritoneal Dialysis Solution Exchange process, or 2) a MMS High Temperature Cap (Model 190259) when the bag connector is removed.
    Device Description
    Not Found
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