BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CDI (TM) SYSTEM 100 MONITORING SYSTEM

    Reg #: 1828100 · FEI: 1828100 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Registration Number
    1828100
    FEI Number
    1828100
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6200 Jackson Road
    City
    ANN ARBOR
    State
    MI
    ZIP
    48103
    Country
    US

    Regulatory Submissions

    510(k) Number
    K902654

    Owner / Operator

    Firm Name
    Terumo Cardiovascular Systems Corp.
    Operator Number
    10039199
    Address
    6200 Jackson Road
    City
    Ann Arbor
    State
    MI
    Postal Code
    48103
    Country
    US
    Correspondent
    Lisa Hessabi

    Products

    Device Name Product Code
    Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass DRY
    Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass DTY

    Proprietary Names

    CDI (TM) SYSTEM 100 MONITORING SYSTEM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198