BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cogent Hemodynamic Monitoring System

    Reg #: 3013319212 · FEI: 3013319212 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ICU MEDICAL, INC.
    Registration Number
    3013319212
    FEI Number
    3013319212
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    600 N Field Dr
    City
    Lake Forest
    State
    IL
    ZIP
    60045
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152006

    Owner / Operator

    Firm Name
    ICU MEDICAL, INC.
    Operator Number
    2025816
    Address
    951 Calle Amanecer, --
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    Products

    Device Name Product Code
    Oximeter DQA
    Blood Pressure Cuff DXQ

    Proprietary Names

    Cogent Hemodynamic Monitoring System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198