BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SetSource Ext Sets

    Reg #: 1713468 · FEI: 1713468 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ICU MEDICAL, INC
    Registration Number
    1713468
    FEI Number
    1713468
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4455 ATHERTON DR.
    City
    Salt Lake City
    State
    UT
    ZIP
    84123
    Country
    US

    Regulatory Submissions

    510(k) Number
    K964435

    Owner / Operator

    Firm Name
    ICU MEDICAL, INC.
    Operator Number
    2025816
    Address
    951 Calle Amanecer, --
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    Products

    Device Name Product Code
    Stopcock, I.V. Set FMG

    Proprietary Names

    SetSource Ext Sets Primary IV Set

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device Manufacture Medical Device