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510(k) Data Aggregation

    K Number
    K091389
    Device Name
    EQUALSHIELD LUER LOCK CONNECTOR PAIR
    Manufacturer
    PLASTMED, LTD.
    Date Cleared
    2009-10-22

    (164 days)

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

    PLASTMED, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
    Device Description
    The EQUASHIELD™ Luer Lock Connector Pair is a closed system for drug transfer. It utilizes some of the predicate device components to create a closed system during drug transfer. The EQUASHIELD™ Luer Lock Connector Pair consists of a connector to an infusion set (Female Luer Lock Connector) and a connector to an IV catheter (Male Luer Lock Connector). The connector pair provides closed system protection during connection and disconnection of a fluid path, thereby prohibiting the escape of the hazardous drug and its harmful vapors into the environment by air-tight enclosing of air and all contaminants within the system.
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    K Number
    K083152
    Device Name
    EQUASHIELD SYSTEM
    Manufacturer
    PLASTMED, LTD.
    Date Cleared
    2009-02-02

    (101 days)

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

    PLASTMED, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EQUASHIELD™ Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
    Device Description
    EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor). The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.
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