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    K Number
    K232523
    Device Name
    Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%
    Manufacturer
    Mankind Pharma Limited
    Date Cleared
    2024-04-10

    (236 days)

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

    Mankind Pharma Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sodium Chloride Inhalation Solution, USP 3% and 7% The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Sodium Chloride Inhalation Solution, USP 0.9% The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.
    Device Description
    The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 0.9%, 3% and 7% with a nominal fill volume of 3 mL & 5 mL (0.9%), 4 mL (3%) and 4 mL (7%) and supplied in single-use low density polyethylene (LDPE) vials.
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