BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EZ IO 45MM 15GA SET

    Reg #: 3015997711 · FEI: 3015997711 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KATMAI INTEGRATED SOLUTIONS
    Registration Number
    3015997711
    FEI Number
    3015997711
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    34 Kelley Way
    City
    Brilliant
    State
    OH
    ZIP
    43913
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091140

    Owner / Operator

    Firm Name
    Katmai Health Services, LLC
    Operator Number
    10050389
    Address
    701 E. Tudor Rd., Suite 215
    City
    Anchorage
    State
    AK
    Postal Code
    99503
    Country
    US
    Correspondent
    Lisa Talkington

    Products

    Device Name Product Code
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    EZ IO 45MM 15GA SET EZ IO DRIVER EZ-IO Needle Sets EZ-IO N/S intraossoeus infusion kit 15Ga x 15 MM Pediatric

    Establishment Types

    Repack or Relabel Medical Device