BEUDAMED
    FDA Registration Active 🇺🇸 United States

    K070839

    Reg #: 1319639 · FEI: 1000138054 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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
    K070839

    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
    Reservoir, Blood, Cardiopulmonary Bypass DTN

    Proprietary Names

    K070839 Capiox Flexible Venous Reservoir Bag CXFVR1500X Capiox Flexible Venous Reservoir Bag with X-coating Capiox Flexible Venous Reservoir Bag CXFVR1500XC Capiox Flexible Venous Reservoir Bag with X-coating AFFINITY® NT Hollow Fiber Oxygenator MINIMAX® Venous Reservoir Bag INTERSEPT® Venous Reservoir Bag, 1000 ml MAXIMA® Venous Reservoir Bag AFFINITY® Venous Reservoir Bag MYOtherm¿ XP Cardioplegia Delivery System MVR Venous Reservoir Bag Resting Heart Module CARDIOTOMY ADAPTER Silicone Assist Reservoir AFFINITY® NT Cardiotomy Venous Reservoir Reservoir, Blood Collection, Hardshell Capiox Flexible Venous Reservoir Bag with X-coating

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)