Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060389
    Device Name
    CONFIDOSE IM AUTO-INJECTOR
    Manufacturer
    Date Cleared
    2006-06-06

    (112 days)

    Product Code
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHARMA-PEN, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ConfiDose™ IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ConfiDose™ IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDose™ IM auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.
    Device Description
    The ConfiDose™ IM auto-injector consists of a syringe cartridge with prefixed needle, power pack housing with spring loaded mechanism to insert a hypodermic needle into a patient to predetermined depth below the skin surface and a window tube with springloaded retraction mechanism. It is pressure actuated. Once activated, the device automatically performs all three steps of the injection process, needle insertion, drug injection and needle withdrawal. The ConfiDose™ IM auto-injector is individually packaged and ETO sterilized for single use.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1