BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Reservoir Hardhsell, 150U

    Reg #: 2029015 · FEI: 1000160458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029015
    FEI Number
    1000160458
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    687 S Wanamaker Ave
    City
    Ontario
    State
    CA
    ZIP
    91761
    Country
    US

    Regulatory Submissions

    510(k) Number
    K932890

    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
    Apparatus, Autotransfusion CAC

    Proprietary Names

    Reservoir Hardhsell, 150U Reservoir Hardshell, 20U CELL SAVER, STEP DOWN ADAPTER Y Connector with Check Valve RESERVOIR, HARD-SHELL, 40U ASPIRATON/ANTICOAGULATION SETS HIGHSPEED CELLSAVER5/5+BOWLSET RBC Bag w/ Twist Lock 1000mL Cell Saver 5/5+ Bowl Kit 225mL Cell Saver 5/5+ BMB Bowl Kit 125mL Y Sets with Extension Line

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)