BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PROTECTIV

    Reg #: 1219611 · FEI: 1219611 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ICU Medical, Inc.
    Registration Number
    1219611
    FEI Number
    1219611
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    201 W Queen St
    City
    SOUTHINGTON
    State
    CT
    ZIP
    06489
    Country
    US

    Regulatory Submissions

    510(k) Number
    K990236

    Owner / Operator

    Firm Name
    ICU Medical, Inc.
    Operator Number
    8020727
    Address
    951 Calle Amanecer
    City
    San Clemente
    State
    CA
    Postal Code
    92673
    Country
    US
    Correspondent
    Michelle Doherty

    Products

    Device Name Product Code
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ

    Proprietary Names

    PROTECTIV Jelco Cathlon Jelco ProtectIV-W Safety IV Catheter Jelco ProtectIV Plus-W Safety IV Catheter Optiva Jelco-W I.V. Catheter

    Establishment Types

    Manufacture Medical Device