BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set

    Reg #: 9680579 · FEI: 1000203464 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Sterigenics Radiation Technologies Canada, Inc
    Registration Number
    9680579
    FEI Number
    1000203464
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1425 KEBET WAY
    City
    PORT COQUITLAM British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K070049

    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
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX
    Hemodialysis System For Home Use ONW

    Proprietary Names

    Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set COMBI SET® 2008 Series 8 mm Home Hemodialysis with Prime Bag

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)