BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    InfuSystem Inc.

    Reg #: 3012337868 · FEI: 3012337868 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    InfuSystem Inc.
    Registration Number
    3012337868
    FEI Number
    3012337868
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    5035 Timberlea Blvd, Unit 3
    City
    Mississauga Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K111275

    Owner / Operator

    Firm Name
    InfuSystem Inc.
    Operator Number
    10052123
    Address
    11130 Strange Line Rd.
    City
    Lenexa
    State
    KS
    Postal Code
    66215
    Country
    US
    Correspondent
    Melissa Mackey

    US Agent

    Business Name
    InfuSystem Inc.
    Contact Name
    Melissa Mackey
    Address
    11130 Strang Line Rd.
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US
    Email
    [email protected]
    Phone
    913 5298933

    Products

    Device Name Product Code
    Pump, Infusion FRN
    Pump, Infusion, Pca MEA
    Infusion Safety Management Software PHC
    Accessories, Pump, Infusion MRZ
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Set, Administration, Intravascular FPA
    Oximeter DQA
    Pump, Infusion, Enteral LZH

    Proprietary Names

    CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Medfusion 3500 Syringe Pump CADD Legacy One CUE AMBULATORY VOLUMETRIC INFUSION PUMP CADD External Power Pack Alaris PC Unit Model 8000 and 8015 Spectrum IQ Infusion System with Dose IQ Safety Software Q CORE Sapphire Pump Baxter Spectrum BD Alaris System with Guardrails Suite MX v12.1.2 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198