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510(k) Data Aggregation

    K Number
    K970800
    Device Name
    MAXCESS NEEDLEFREE - Y- SITE (100713)
    Manufacturer
    SOLOPAK MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-04-02

    (29 days)

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

    SOLOPAK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.
    Device Description
    The Douglas Medical Products Maxcess™ NeedleFree Y-Site is a sterile, nonpyrogenic component packaged in a tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess™ NeedleFree Y-Site have been tested per tripartite guidelines and is safe for it's intended use.
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    K Number
    K962663
    Device Name
    SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET
    Manufacturer
    SOLOPAK MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-10-04

    (88 days)

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

    SOLOPAK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml) .
    Device Description
    The SoloPak® Sidekick Infusion Pump is individually packaged and can be cleaned and reused for multiple infusions. The Administration Set is sterile, non-pyrogenic, and packaged in a tyvek/polyethylene pouch. It is a single use set. The materials used to manufacture the SoloPak Sidekick Infusion Pump and Administration Set are the same as those used in currently legally marketed products with the same intended uses.
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    K Number
    K963355
    Device Name
    SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET
    Manufacturer
    SOLOPAK MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-10-04

    (39 days)

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

    SOLOPAK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter.
    Device Description
    The pump is made of two cylindrical high impact plastic shells with a pressure plate assembly in the top shell. It is packaged individually and can be cleaned after each use and reused. The Administration Sets that function with the pump consists of a 110mL PVC drug container, PVC tubing, a fill valve, PVC tubing, an onloff clamp, a 1.2 Micron Filter, a male Luer lock adapter with an integrated flow restrictor and tip protectors. The administration Sets are individually packaged as single use devices in tyvek and mylar pouches. They are EtO stenlized per AAMI guidelines and meet the requirements of the Federal Register Vol. 43, No. 122, June 23,1978, pp 27482-3 for ethylene oxide residuals.
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    K Number
    K960661
    Device Name
    MAXCESS NEEDLE FREE CONNECTOR (8200)
    Manufacturer
    SOLOPAK MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-03-21

    (34 days)

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

    SOLOPAK MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.
    Device Description
    The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The Douglas Medical Products Maxcess Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products.
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