BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER

    Reg #: 1644312 · FEI: 1000117748 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MedXL
    Registration Number
    1644312
    FEI Number
    1000117748
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3204 Hale Rd
    City
    ARDMORE
    State
    OK
    ZIP
    73401
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102043

    Owner / Operator

    Firm Name
    MEDXL
    Operator Number
    10089418
    Address
    3204 Hale Road
    City
    Ardmore
    State
    OK
    Postal Code
    73401
    Country
    US
    Correspondent
    Steve T Adamietz

    Products

    Device Name Product Code
    Catheter, Hemodialysis, Implanted MSD

    Proprietary Names

    ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)