BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Breeze Sleepgear with Dreamseal

    Reg #: 2024500 · FEI: 2024500 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    COVIDIEN
    Registration Number
    2024500
    FEI Number
    2024500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2101 Faraday Avenue
    City
    CARLSBAD
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K002001

    Owner / Operator

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

    Products

    Device Name Product Code
    Ventilator, Non-Continuous (Respirator) BZD

    Proprietary Names

    Breeze Sleepgear with Dreamseal

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility