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510(k) Data Aggregation

    K Number
    K122969
    Device Name
    CLICKFINE PEN NEEDLE
    Manufacturer
    P/L Biomedical
    Date Cleared
    2012-10-25

    (29 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    P/L Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clickfine pen needle is intended for the hypodermic injection of insulin into the body when attached to an injection pen.
    Device Description
    The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and suapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the insulin is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
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    K Number
    K122971
    Device Name
    CLICKFINE PEN NEEDLE
    Manufacturer
    P/L Biomedical
    Date Cleared
    2012-10-25

    (29 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    P/L Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Clickfine pen needle is intended for the hypodermic injection of fluids into the body when attached to an injection pen.
    Device Description
    The Ypsomed Clickfine Pen Needles are sterile, non-pyrogenic, single use needles designed to be used with commercially available pen-injectors for the administration of prescribed fluids. Each needle is individually packaged in a sealed protective container with a peel tab. The pen needles are used by peeling back the peel tab and snapping or screwing the hub onto the threaded end of the pen injector. The back end of the cannula punctures the rubber injection port of the drug reservoir in the peninjector. The outer protective cap is then removed. The inner protective cap will remain over the needle until the drug is ready to be injected. When the injection is needed, the inner protective cap is removed and the needle is inserted into the chosen site. The pen-injector automatically delivers the fluid through the needle. The protective cap is replaced and the needle is then removed, safely discarded and replaced with a new needle.
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    K Number
    K972135
    Device Name
    MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET
    Manufacturer
    P/L Biomedical
    Date Cleared
    1997-08-26

    (81 days)

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

    P/L Biomedical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Subcutaneous Infusion Sets with Indwelling Catheters are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.
    Device Description
    The general description, operation, construction and use of the Maersk Medical Pureline™ Subcutaneous Infusion Sets With Indwelling Catheters has not changed as a result of the modifications. They remain sterile, non-pyrogenic, single use subcutaneous infusion sets designed to be used with commercially available infusion devices. There are two basic components provided for each device. The first is a stand-alone subcutaneous indwelling catheter. This catheter is provided as an integral assembly with a Teflon cannula, adhesive backed fixation tape, an iniection port and the female portion of a proprietary plastic "click-lock" connector. The catheter assembly comes with a stainless steel insertion cannula. The insertion cannula is mounted to a male portion of the proprietary plastic "click-lock" connector. The insertion cannula is come to the user inserted through the injection port and the inner lumen of the Teflon catheter with the needle end protruding past the tip of the catheter. The male connector is locked to the female connector on the indwelling catheter. A needle protector is assembled over the Teflon catheter and the insertion cannula. A separate male portion of the proprietary connector without the insertion cannula is provided in the package. This component is used to attach to the female connector of the catheter after the indwelling Teflon cannula has been inserted and the steel insertion cannula has been withdrawn. The connector protects the indwelling catheter when the infusion set is not attached. The second component of the Maersk Medical Subcutaneous infusion Set with Indwelling Catheter is the infusion set. The infusion set is comprised of a co-extruded tube with a female luer lock connector at the pump end and a stainless steel needle incorporated into the male portion of the proprietary plastic "click-lock" connector at the patient end. In order to maintain the sterility of the infusion path, a male luer cap covers the female luer lock connector and the male "click-lock" connector comes attached to a mating female connector. The sets come packaged in blister packs sealed with paper lid stock.
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