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510(k) Data Aggregation

    K Number
    K991575
    Device Name
    PRIMUS STEAM STERILIZERS
    Manufacturer
    PRIMUS STERILIZER CO., INC.
    Date Cleared
    1999-12-03

    (211 days)

    Product Code
    FLE, FIF
    Regulation Number
    880.6880
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRIMUS STERILIZER CO., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are available in the following configurations: 13" x 13" x 23" Multi-Functional Sterilizer Single Door 13" x 13" x 23" Laboratory/Lo Single Door 16" x 16" x 26" Multi-Functional Sterilizer Single or Double Door 16" x 16" x 26" Laboratory/Lo Single or Double Door 20" x 20" x 38" Multi-Functional Sterilizer Single or Double Door 20" x 20" x 38" Laboratory/Lo Single or Double Door 26" x 26" x 39" Multi-Functional Sterilizer Single or Double Door 26" x 26" x 39" Laboratory/Lo Single or Double Door 26" x 26" x 49" Multi-Functional Sterilizer Single or Double Door 26" x 26" x 49" Laboratory/Lo Single or Double Door 26" x 26" x 67" Multi-Functional Sterilizer Single or Double Door 26" x 26" x 67" Laboratory/Lo Single or Double Door 26" x 36" x 39" Multi-Functional Sterilizer Single or Double Door 26" x 36" x 39" Laboratory/Lo Single or Double Door 26" x 36" x 48" Multi-Functional Sterilizer Single or Double Door 26" x 36" x 48" Laboratory/Lo Single or Double Door 26" x 36" x 60" Multi-Functional Sterilizer Single or Double Door 26" x 36" x 60" Laboratory/Lo Single or Double Door 26" x 63" x 48" Multi-Functional Sterilizer Single or Double Door 26" x 63" x 48" Laboratory/Lo Single or Double Door 26" x 63" x 76" Multi-Functional Sterilizer Single or Double Door 26" x 63" x 76" Laboratory/Lo Single or Double Door Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the wacuum and gravity cycles as well as a low temperature feature for pasteurization and inspissation processes.
    Device Description
    The PRIMUS PSS series steam sterilizers are class II medical devices as defined by 21 CFR 880.6880. The PSS series sterilizers feature fully jacketed, rectangular 316L stainless steel chambers with sliding doors. The units are available in Multifunction or Laboratory/Lo configurations. The Multifunction units offer both prevacuum and gravity configurations, whereas the Laboratory/Lo units offer prevacuum, gravity, and a low operating temperature configuration. The PRIMUS PSS series sterilizers are offered for sale with the following factory-set sterilization cycles and cycle values: CYCLES | STERILIZE TEMP | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD ---|---|---|---|--- GRAVITY | 132° C | 4 MINUTES | 1 MINUTE | HARD GOODS VACUUM | 132° C | 4 MINUTES | 15 MINUTES | WRAPPED GOODS LIQUIDS | 121° C | 30 MINUTES | *8 MINUTES | LIQUIDS TEST (VAC) | 132° C | 4 MINUTES | 3 MINUTES | BOWIE-DICK TEST *Liquid Cycle is Cool Time
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