BEUDAMED
    FDA Registration Active 🇺🇸 United States

    RESCUE MASK

    Reg #: 1419464 · FEI: 1419464 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    RONDEX PRODUCTS, INC.
    Registration Number
    1419464
    FEI Number
    1419464
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    324 N GARDINER AVE
    City
    Rockford
    State
    IL
    ZIP
    61107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K834250

    Owner / Operator

    Firm Name
    RONDEX PRODUCTS, INC.
    Operator Number
    1419464
    Address
    324 NORTH GARDINER AVE., --
    City
    Rockford
    State
    IL
    Postal Code
    61107
    Country
    US
    Correspondent
    GENE R BALDWIN

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    RESCUE MASK

    Establishment Types

    Manufacture Medical Device