BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Guardian Warmer

    Reg #: 1419937 · FEI: 1419937 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDELA LLC
    Registration Number
    1419937
    FEI Number
    1419937
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1101 CORPORATE DR.
    City
    MCHENRY
    State
    IL
    ZIP
    60050
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122449

    Owner / Operator

    Firm Name
    MEDELA AG
    Operator Number
    8030974
    Address
    LAETTICHSTRASSE 4b, --
    City
    BAAR
    State
    CH-NOTA
    Postal Code
    CH-6340
    Country
    CH

    Products

    Device Name Product Code
    Warmer, Thermal, Infusion Fluid LGZ

    Proprietary Names

    Guardian Warmer

    Establishment Types

    Manufacture Medical Device