BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Transfer Bag, CLX 1000ML - 732-37M

    Reg #: 2953359 · FEI: 3000215205 · 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
    2953359
    FEI Number
    3000215205
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2311 Lincoln Ave
    City
    Hayward
    State
    CA
    ZIP
    94545
    Country
    US

    Regulatory Submissions

    510(k) Number
    BK840010

    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
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR

    Proprietary Names

    Transfer Bag, CLX 1000ML - 732-37M Transfer Bag, 400ML, Barrel Leads - 732-42M Transfer Bag 600 ML (MEDTRONIC) - ATBAG600 Transfer Bag 300 ML - 732-32M Transfer Bag 600ML - 732-33M Transfer Pack - NFP450 Transfer Bag, 600ML, Multi-Lead Set - 732-40M Transfer Bag 1000 ML (MEDTRONIC) - ATBAG1000 Transfer Bag 300 ML (MEDTRONIC) - ATBAG300 TRANSFER PACK NFP450E TRANSFER PACK NFP450B

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)