BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sodium Chloride Inhalation Solution, 10%

    Reg #: 3016360883 · FEI: 3001237796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    The Ritedose Corporation
    Registration Number
    3016360883
    FEI Number
    3001237796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1135 Performance Parkway
    City
    Columbia
    State
    SC
    ZIP
    29203
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210126

    Owner / Operator

    Firm Name
    The Ritedose Corporation
    Operator Number
    9030287
    Address
    1 TECHNOLOGY CIRCLE, --
    City
    Columbia
    State
    SC
    Postal Code
    29203
    Country
    US
    Correspondent
    Arianne - Lindsey

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    Sodium Chloride Inhalation Solution, 10% Sodium Chloride Inhalation Solution, 3.5% Sodium Chloride Inhalation Solution, 3% Sodium Chloride Inhalation Solution, 7%

    Establishment Types

    Manufacture Medical Device