BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PulmoSal (pH+) 7%, pH 7.4

    Reg #: 3007177643 · FEI: 3007177643 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ASEPT PAK INC.
    Registration Number
    3007177643
    FEI Number
    3007177643
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    64 West Street
    City
    Malone
    State
    NY
    ZIP
    12953
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130091

    Owner / Operator

    Firm Name
    Asept Pak Inc.
    Operator Number
    10024698
    Address
    64 West Street
    City
    Malone
    State
    NY
    Postal Code
    12953
    Country
    US
    Correspondent
    Tracy M Roth

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    PulmoSal (pH+) 7%, pH 7.4

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device