BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K900640

    Reg #: 2029275 · FEI: 1000306431 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    12
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    2029275
    FEI Number
    1000306431
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    344 Bonnie Cir
    City
    Corona
    State
    CA
    ZIP
    92878
    Country
    US

    Regulatory Submissions

    510(k) Number
    K900640

    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
    Heat-Exchanger, Cardiopulmonary Bypass DTR

    Proprietary Names

    K900640 Condc/TPBT; 4:1 Bridged 6376 Sarns Cardioplegia Set Conducer/MP4; 4:1 No Recirc 165720 Sarns Cardioplegia Set Condc/CP/MP4; 4:1 Bridged 6375 Sarns Cardioplegia Set Condc/MP4 Set; 2:1 No Recirc 9499 Sarns Cardioplegia Set Cardioplegia Delivery Set, 4:1 BIOTHERM HEAT EXCHANGER MYOtherm¿ XP Cardioplegia Delivery System Cardioplegia Extension Line 165720, 9457, 6376, 6375 Sarns Cardioplegia Set 9457 Sarns Cardioplegia Set Condc/CP Set; 4:1 No Recirc 9457 Sarns Cardioplegia Set

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)