BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ICU Medical, Inc.

    Reg #: 3008818980 · FEI: 3008818980 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    3008818980
    FEI Number
    3008818980
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9124 Polk Lane, Suite 101
    City
    Olive Branch
    State
    MS
    ZIP
    38654
    Country
    US

    Regulatory Submissions

    510(k) Number
    K023793

    Owner / Operator

    Firm Name
    ICU Medical, Inc.
    Operator Number
    8020727
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    Products

    Device Name Product Code
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Mask, Oxygen, Non-Rebreathing KGB

    Proprietary Names

    PEDIPLUS MANUAL RESUSCITATOR First Breath NON-REBREATHING MASK

    Establishment Types

    Manufacture Medical Device