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510(k) Data Aggregation

    K Number
    K220145
    Device Name
    Monaghan medical filtered mouthpiece kit
    Date Cleared
    2023-08-24

    (582 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Monaghan Medical Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The filter kit is intended for single patient use as an accessory to a small volume nebulizer. The device can be used in a hospital, home, or clinic environment with patients 5 years and above to minimize the amount of medical aerosol exhaled into the air.
    Device Description
    The Filtered Mouthpiece is an accessory to the AeroEclipse® BANTM nebulizer. The filtered mouthpiece kit will be sold as a stand-alone filter kit or as part of a kit with the AeroEclipse® BAN™ nebulizer. The replacement filters can be purchased in bulk pack. The device is a tube with a port to a check valve and a filter element. On inhalation the flow is straight through the tube from the nebulizer to the patient with a check valve preventing air from the filter exhaust from backflowing and diluting the delivered aerosol. On exhalation the check valve opens and all flow is directed through a filter to capture exhaled aerosol particles. This minimizes fugitive emissions from therapies such a methacholine challenge test or the delivery of antibiotics. The filter consists of a plastic body, which incorporates a mechanical filter pad (Synthetic Fibers and Foam) and connectors (male / female).
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    K Number
    K110273
    Device Name
    AEROVENT PLUS CHC
    Date Cleared
    2011-06-09

    (129 days)

    Product Code
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    MONAGHAN MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The AeroVent Plus™ CHC is a single patient use collapsible holding chamber that provides the means of delivering MDI packaged drugs into a ventilator breathing circuit. The intended environments for use include the home, hospitals and clinics.
    Device Description
    The AeroVent Plus™ Collapsible Holding Chamber (CHC) is a single patient use device used for the administration of MDI packaged drugs to mechanically ventilated patients without the need to compromise the integrity of the breathing circuit by having to open the circuit to administer the medication. The AeroVent Plus™ CHC remains collapsed in the breathing circuit until such time that a treatment is required. The AeroVent Plus™ CHC is then expanded while remaining in the circuit and treatment is given. Upon completion of the treatment the AeroVent Plus™ CHC is then once again collapsed in the circuit. It is designed only for use in the inspiratory limb of a breathing circuit, to accommodate conventional pMDI canisters as well as most pMDI canisters with integrated dose counters (GSK type) while maintaining the counter function.
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