BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Q CORE Sapphire Pump

    Reg #: 3004906872 · FEI: 3004906872 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    InfuSystem Inc.
    Registration Number
    3004906872
    FEI Number
    3004906872
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11130 Strang Line Rd.
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161667

    Owner / Operator

    Firm Name
    InfuSystem Inc.
    Operator Number
    10029405
    Address
    11130 Strang Line Rd.
    City
    Lenexa
    State
    KS
    Postal Code
    66215
    Country
    US
    Correspondent
    Melissa Mackey

    Products

    Device Name Product Code
    Accessories, Pump, Infusion MRZ
    Pump, Infusion FRN

    Proprietary Names

    Q CORE Sapphire Pump

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198