BEUDAMED
    FDA Registration Active 🇺🇸 United States

    2008K@HOME HEMODIALYSIS MACHINE

    Reg #: 1225714 · FEI: 3001451489 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Registration Number
    1225714
    FEI Number
    3001451489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    920 WINTER STREET
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070049

    Owner / Operator

    Firm Name
    Fresenius Medical Care North America
    Operator Number
    9030510
    Address
    920 WINTER STREET, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    Products

    Device Name Product Code
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX
    Hemodialysis System For Home Use ONW

    Proprietary Names

    2008K@HOME HEMODIALYSIS MACHINE CombiSet - 2008 Series Home Hemodialysis with Prime Bag

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198