BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Orbit Hemodialysis Catheter

    Reg #: 3035111606 · FEI: 3035111606 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GAMAMED VASCULAR SYSTEMS INC.
    Registration Number
    3035111606
    FEI Number
    3035111606
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1607 Capitol Ave Suite 327
    City
    Cheyenne
    State
    WY
    ZIP
    82001
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102833

    Owner / Operator

    Firm Name
    Gamamed Vascular Systems Inc.
    Operator Number
    10092344
    Address
    1607 Capitol Ave Suite 327
    City
    Cheyenne
    State
    WY
    Postal Code
    82001
    Country
    US
    Correspondent
    Lorena Arrieche

    Products

    Device Name Product Code
    Catheter, Hemodialysis, Non-Implanted MPB

    Proprietary Names

    Orbit Hemodialysis Catheter

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device