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510(k) Data Aggregation

    K Number
    K082541
    Device Name
    HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM
    Date Cleared
    2008-11-26

    (85 days)

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

    MEDI NUCLEAR CORP., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is indicated to aerosolize medication approved for nebulization and prescribed by a physician. This Healthline MEDICATOR®/RediNeb® Aerosol Drug Delivery System is intended for adult and pediatric patients consistent with the indications for delivery of aerosolized medication to/or through the patient's pulmonary system. The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools, and long term care facilities.
    Device Description
    The MEDICATOR®/RediNeb® Aerosol Drug Delivery System is a miniaturized nebulizer attached to a valved manifold. During patient inhalation, aerosol mist being generated from the nebulizer is substantially increased through Breath-Enhancement technology, and configuration is such that a filter can be added to the air exit port if so desired.
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    K Number
    K080969
    Device Name
    HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
    Date Cleared
    2008-07-25

    (112 days)

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

    MEDI NUCLEAR CORP., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Healthline RediNeb® Small Volume Medication Nebulizer (SVN) is indicated to aerosolize medication approved for nebulization by a physician. The Healthline RediNeb® Medication Nebulizer is intended for adult and pediatric patients consistent with the indications for aerosolized medication to or through the patient's pulmonary system. The RediNeb® Nebulizer device is for patient use in all areas where the administration of medication by aerosol means is warranted. This includes hospital/institutional settings, home care use, schools and long term care facilities.
    Device Description
    The RediNeb® is basically a miniaturized jet nebulizer, functioning very similarly to both of the predicate devices. Physical differences are that the maximum fill volume is 3 ml versus 6ml and design is such that the RediNeb® can be incorporated with breath enhanced features of a manifold delivery body. The RediNeb® nebulizer, though very small in size (creating minimal waste if used once and discarded), is fabricated of polymers such that it may be properly cleaned for reuse multiple times.
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    K Number
    K080657
    Device Name
    NEB-90 LARGE VOLUME MEDICATION NEBULIZER
    Date Cleared
    2008-06-30

    (115 days)

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

    MEDI NUCLEAR CORP., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Neb-90™ Large Volume Medication Nebulizer is indicated for the continuous aerosol administration of respiratory medication (inhalable solution) including, but not necessarily limited to, beta adrenergic bronchodilator (albuterol sulfate) and/or a wetting agent such as sodium chloride solution (saline) that is used for the treatment of respiratory and related diseases and conditions including, but not necessarily limited to asthma, COPD, bronchiolitis and cystic fibrosis. The Neb-90™ Large Volume Medication Nebulizer is for use in hospital Emergency Department, ICU or other similar settings for delivery of aerosolized medication to patients undergoing severe respiratory distress.
    Device Description
    The Nebulizer is a single patient/single use device which is filled with a fluid, typically respiratory medication and connected to a gas source via flexible tubing. The nebulizer works by Pavipng a cluid come into contact with the stream of gas. The gas shatters the liquid into small particles. These particles then impact a baffle that further reduces the size of the particles. The majority of the larger particles settle inside the nebulizer as a result of gravity and inertia, returning the mist to liquid to repeat the nebulization process. The smaller particles are then administered as the patient inhales. The treatment is completed when the majority of liquid has been nebulized.
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