BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Blood Set

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3002907620
    FEI Number
    3002907620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1700 College Blvd.
    City
    West Memphis
    State
    AR
    ZIP
    72301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K993120

    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
    Set, Blood Transfusion BRZ

    Proprietary Names

    Blood Set Blood Set with Handpump Y-Type Blood Set Interlink Y Type Blood Set Y-Type Blood Solution Set w/Pressure Pump Y-Type Blood Set with Handpump Clearlink Y-Type Blood Set, 170-260 Filter Clearlink Fenwal Blood Set, Y-Type, Large 170-260 Filter Blood Recipient Set

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)