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510(k) Data Aggregation

    K Number
    K121803
    Device Name
    INTRAVASCULAR ADMINISTRATION SET
    Manufacturer
    ACTA MEDICAL LLC
    Date Cleared
    2012-12-19

    (183 days)

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

    ACTA MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acta Medical Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Acta Medical infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.
    Device Description
    Acta Medical, LLC Intravascular administration set is sterile/pvrogen free. non-DEHP PVC tubing with the following combination of components. - Universal Spike. - Drip chamber with 15 micron filter. - Non-DEHP PVC tubing. - Flow Regulator. - Roller clamp. - Slide clamp. - Luer locks. - Filters. - Latex free "Y" site or pre-approved needleless "Y" site for secondary infusions or medication administration.
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    K Number
    K121161
    Device Name
    EMPTY EVA SOLUTION CONTAINER EMPTY EVA DUAL CHAMBER SOLUTION CONTAINER
    Manufacturer
    ACTA MEDICAL LLC
    Date Cleared
    2012-07-13

    (87 days)

    Product Code
    KPE
    Regulation Number
    880.5025
    Why did this record match?
    Applicant Name (Manufacturer) :

    ACTA MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An Empty Container with sterile fluid pathway used to store intravenous solution for administration to patient. Medication transfer in and out of the container is done using aseptic technique.
    Device Description
    Acta Medical Empty EVA Solution Container is designed to hold intravenous fluid in a single chamber or in dual chambers separated by a separating partition. Empty EVA Solution Container and Empty EVA Dual Chamber Solution Container has fill ports to fill single and dual chambers, latex free injection port for additions of injectable additives and a spike port to connect intravascular administration tubing. The fill port tubing has a sealing clamp to secure the contents during storage post filling and prior to their administration.
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