BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Speaking Valve with Oxygen Port

    Reg #: 9681384 · FEI: 3002807626 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Covidien
    Registration Number
    9681384
    FEI Number
    3002807626
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Avenue Henequen No. 1181, Park Industrial Salvarcar
    City
    Ciudad Juarez Chihuahua
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K945407

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    US Agent

    Business Name
    Covidien
    Contact Name
    Kae Miller
    Address
    6135 Gunbarrel Ave
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US
    Email
    [email protected]
    Phone
    303 8768859

    Products

    Device Name Product Code
    Tube, Tracheostomy (W/Wo Connector) BTO

    Proprietary Names

    Speaking Valve with Oxygen Port SSVO

    Establishment Types

    Repack or Relabel Medical Device