BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    VitalFlow Set

    Reg #: 9611665 · FEI: 3002807095 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Sterigenics EO Canada, Inc.
    Registration Number
    9611665
    FEI Number
    3002807095
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    400 Ambassador Drive
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K240880

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Blood Pump For Ecmo, Long-Term (> 6 Hours) Use QNR
    Oxygenator, Long Term Support Greater Than 6 Hours BYS
    Tubing, Long Term Support Greater Than 6 Hours QWF
    Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure QJZ

    Proprietary Names

    VitalFlow Set

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)