BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Elk. RX15 Oxy/4LRes. Right Port; XC 3CX*RX15RE40 Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating

    Reg #: 1319639 · FEI: 1000138054 · 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
    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
    K062381

    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
    Oxygenator, Cardiopulmonary Bypass DTZ

    Proprietary Names

    Elk. RX15 Oxy/4LRes. Right Port; XC 3CX*RX15RE40 Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating Elk. RX15 Oxygenator; Left Port; XC 3CX*RX15W Capiox RX Oxygenator with X-coating Elk. RX25 Oxy/4LRes. Right Port; XC 3CX*RX25RE Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating Elk. RX15 Oxy/4LRes. Left Port; XC 3CX*RX15RW40 Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating K062381 Elk. RX15 Oxygenator; Right Port; XC 3CX*RX15E Capiox RX Oxygenator with X-coating Elk. RX15 Oxy/3LRes. Left Port; XC 3CX*RX15RW30 Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating Elk. RX25 Oxy/4LRes. Left Port; XC 3CX*RX25RW Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating Elk. RX25 Oxygenator; Right Port; XC 3CX*RX25E Capiox RX Oxygenator with X-coating Elk. RX25 Oxygenator; Left Port; XC 3CX*RX25W Capiox RX Oxygenator with X-coating Elk. RX15 Oxy/3LRes. Right Port; XC 3CX*RX15RE30 Capiox RX Oxygenator with Hardshell Venous Reservoir with X-coating

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)