BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TUB06HPR Heated CPAP Tube

    Reg #: 3010834934 · FEI: 3010834934 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    Sunset Healthcare Solutions Central Warehouse
    Registration Number
    3010834934
    FEI Number
    3010834934
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2725 Alft Lane
    City
    Elgin
    State
    IL
    ZIP
    60124
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201418

    Owner / Operator

    Firm Name
    Sunset Healthcare Solutions
    Operator Number
    9106379
    Address
    141 West Jackson Boulevard, 1950
    City
    Chicago
    State
    IL
    Postal Code
    60604
    Country
    US
    Correspondent
    JOSEPH - CONSOLI

    Products

    Device Name Product Code
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE

    Proprietary Names

    TUB06HPR Heated CPAP Tube

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device