BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Medline Industries - Arlington Heights

    Reg #: 1417411 · FEI: 1417411 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    22
    Establishment Types
    3
    Classifications
    5

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    Registration Details

    Registration Name
    Medline Industries - Arlington Heights
    Registration Number
    1417411
    FEI Number
    1417411
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    900 W. University Drive,
    City
    ARLINGTON HEIGHTS
    State
    IL
    ZIP
    60004
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153010

    Owner / Operator

    Firm Name
    Medline Industries, LP
    Operator Number
    1417592
    Address
    Three Lakes Drive
    City
    Northfield
    State
    IL
    Postal Code
    60093
    Country
    US
    Correspondent
    Stephanie Augsburg

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Dressing, Wound, Drug FRO
    Lavage, Jet FQH
    Humidifier Nebulizer Kit OGG
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT

    Proprietary Names

    Hudson RCI Aquapak Nebulizer Aquapak Nebulizer; Aquapak Saline Reservoir; Aquapak Sterile Water Reservoir Antimicrobial Wound Lavage Medline Humidifier Nebulizer Kit Gibeck Humid-Flo and Passive Kits Aquapak Humidifier Reservoir with Adaptor ISO GARD Breathing Circuit Kit Hudson RCI Conventional Breathing Circuit with Filter Aquapak Nebulizer Reservoir with Adaptor Oxygen Therapy Start-Up Kit Hudson RCI Circuit / Column Kits Comfort Flo Humidification System Hudson RCI Conventional Breathing Circuit with Nebulizer Concha Nebulizer Concha Column ConchaPak Concha Column; Concha Reservoir; ConchaPak; ConchaTherm Brackets; ConchaTherm III; ConchaTherm Thermistor Probes Hudson RCI AddiPak Unit Dose Vial Medline Hudson RCI AquaPak Bubble Prefilled Humidifiers Aquapak Sterile Humidifier Reservoirs AquaPak Humidifier Adapters Addipak Unit Dose Vial

    Establishment Types

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