BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Oro-Nasal NIV Mask

    Reg #: 1922553 · FEI: 1922553 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    HANS RUDOLPH, INC.
    Registration Number
    1922553
    FEI Number
    1922553
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    8325 COLE PKWY
    City
    Shawnee
    State
    KS
    ZIP
    66227
    Country
    US

    Regulatory Submissions

    510(k) Number
    K030515

    Owner / Operator

    Firm Name
    HANS RUDOLPH, INC.
    Operator Number
    1922553
    Address
    8325 Cole Parkway, --
    City
    Shawnee
    State
    KS
    Postal Code
    66227
    Country
    US
    Correspondent
    KEVIN A RUDOLPH

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    Oro-Nasal NIV Mask

    Establishment Types

    Manufacture Medical Device