BEUDAMED
    FDA Registration Active 🇺🇸 United States

    InfuSystem Inc.

    Reg #: 3004906872 · FEI: 3004906872 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    25
    Establishment Types
    1
    Classifications
    18

    Registration Details

    Registration Name
    InfuSystem Inc.
    Registration Number
    3004906872
    FEI Number
    3004906872
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    11130 Strang Line Rd.
    City
    Lenexa
    State
    KS
    ZIP
    66215
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982839

    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
    Pump, Infusion, Pca MEA
    Pump, Infusion FRN
    Set, Administration, Intravascular FPA
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Pump, Infusion, Enteral LZH
    Accessories, Pump, Infusion MRZ
    Infusion Safety Management Software PHC
    Intraoral Cooling Device QUA
    Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) DRO
    Oximeter DQA
    Automated External Defibrillators (Non-Wearable) MKJ
    Dc-Defibrillator, Low-Energy, (Including Paddles) LDD
    Electrocardiograph DPS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) MWI
    Aid, Cardiopulmonary Resuscitation LIX
    System, Network And Communication, Physiological Monitors MSX
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    CADD Legacy PCA Alaris 8015 CADD High Volume Admin Set CADD Prizm Model 6100 Pump Spectrum & Spectrum with Master Drug Library CADD Legacy One Infinity Bags 20, 100, 1200 ML Infusomat Space Alaris 8110 CADD Legacy Plus Cadd Prizm Power Pack Vista Basic Curlin 6000 Smiths CADD Cassette Reservoir 500 ML Bag Enteralite Infinity Set Medfusion 3500 Syringe Pump Q CORE Sapphire Pump Baxter Sigma Spectrum Infusion Pump with Master Drug Library CADD Administration Set Cadd Solis Ambulatory Pump Perfusor Space Cadd Prizm PCSII Enteralite Infinity Enteral Feeding Pump HEARTSTART MRX MONITOR/DEFIBRILLATOR CADD Extension Set

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198