BEUDAMED
    FDA Registration Active 🇺🇸 United States

    3CX*FX15RW30 Capiox FX15 Oxygenator with Arterial Filter

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    Sterigenics U.S., LLC
    Registration Number
    1319639
    FEI Number
    1000138054
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    84 Park Rd
    City
    Queensbury
    State
    NY
    ZIP
    12804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140774

    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
    Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTM
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    3CX*FX15RW30 Capiox FX15 Oxygenator with Arterial Filter 3CX*FX15RW40 Capiox FX15 Oxygenator with Arterial Filter 3CX*FX25RW Capiox FX25 Oxygenator with Arterial Filter 3CX*FX15RE40 Capiox FX15 Oxygenator with Arterial Filter 3CX*FX15RE30 Capiox FX15 Oxygenator with Arterial Filter 3CX*FX25RE Capiox FX25 Oxygenator with Arterial Filter CAPIOX FX Oxygenators and Reservoirs Series

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)