BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BAG ASSY, WASTE, 10 LITER

    Reg #: 2029015 · FEI: 1000160458 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    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
    K101907

    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

    BAG ASSY, WASTE, 10 LITER SEQUESTRATION KITS CS ELITE PROCESSING KIT, 225ML CS ELITE PROCESSING KIT, 70ML CS ELITE PROCESSING KIT, 125ML

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)