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510(k) Data Aggregation

    K Number
    K110262
    Device Name
    SHARPS CONTAINER
    Manufacturer
    Date Cleared
    2011-04-05

    (67 days)

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

    NOBLE MARKETING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Noble Sharps container is a disposable over the counter sharps container that is intended for the safe disposal of used medical sharps. It is intended for use in offices, exam and patient rooms of small quantity healthcare providers such as medical doctors, dentists, and veterinarians. The size of the Sharps Container is 6 7/16" in height x 4 15/16" in width x 2 7/16" in depth. It is designed with 4- individual single use chambers with each holding 1-sharp, with a maximum sharp length of 6 1/8″.
    Device Description
    The Noble Sharps Container are intended to be used at healthcare facilities, including nursing stations, medication carts, laboratories, emergency rooms, treatment rooms, and other small quantity waste generators for the safe disposal of hazardous sharps. The Nobles Sharps Container is a single use device designed for the safe disposal of hazardous sharps. It is designed with 4-chambers, each chamber will hold one sharps. After each chamber is filled with a sharp, a locking lid is closed by pressing downward, thus permanently sealing the sharps inside the container. All materials including the bottom, sides, and locking lid are manufactured using PP7726 (polypropylene) the same material used in the predicate device, the GongDong disposable sharps container cleared under K082042. The size of the Noble Sharps Container is 6 7/16" in height, 4 15/16" in width and 2 7/16" in depth.
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    K Number
    K101380
    Device Name
    RXPEAKFLOW
    Manufacturer
    Date Cleared
    2010-09-13

    (119 days)

    Product Code
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBLE MARKETING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RxPeakFlow is a single patient use device to measure a patient's peak expiratory flow rate in liters/minutes. This is helpful in monitoring respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
    Device Description
    The RxPeakFlow is a device used to measure the peak expiratory flow of a patient. The Peak Expiratory Flow Rate is a recognized lung function value that is helpful in monitoring of respiratory conditions such as asthma. The device can be used anywhere the patient needs to measure their peak expiratory flow rate. It is a single patient use device intended for use for children to adults.
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