BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SUNSET HEALTHCARE SOLUTIONS, Inc.

    Reg #: 3006446479 · FEI: 3006446479 · Expires 2026
    View on FDA
    Products
    45
    Proprietary Names
    57
    Establishment Types
    4
    Classifications
    45

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    Registration Details

    Registration Name
    SUNSET HEALTHCARE SOLUTIONS, Inc.
    Registration Number
    3006446479
    FEI Number
    3006446479
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    141 W Jackson Blvd Ste 1950
    City
    CHICAGO
    State
    IL
    ZIP
    60604
    Country
    US

    Regulatory Submissions

    510(k) Number
    K102626

    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
    Apparatus, Suction, Ward Use, Portable, Ac-Powered JCX
    Nebulizer (Direct Patient Interface) CAF
    Knife, Surgical EMF
    Strap, Head, Gas Mask BTK
    Oximeter, Infrared, Sporting, Aviation OCH
    Unit, Filter, Membrane JRL
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Mask, Oxygen, Low Concentration, Venturi BYF
    Brush, Cleaning, Tracheal Tube EPE
    Flowmeter, Calibration, Gas BXY
    Ventilator, Non-Continuous (Respirator) BZD
    Mask, Oxygen, Non-Rebreathing KGB
    Connector, Airway (Extension) BZA
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    Drain, Tee (Water Trap) BYH
    Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer BZE
    Stimulator, Nerve, Transcutaneous, For Pain Relief GZJ
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Tubing, Noninvasive GAZ
    Flowmeter, Tube, Thorpe, Back-Pressure Compensated CAX
    Orthosis, Lumbar IQE
    Pump, Breast, Powered HGX
    Ventilator, Continuous, Facility Use CBK
    Tubing, Pressure And Accessories BYX
    Bottle, Collection, Vacuum KDQ
    Cannula, Nasal, Oxygen CAT
    Tube, Collection, Capillary Blood GIO
    Airway, Oropharyngeal, Anesthesiology CAE
    Disinfector, Medical Devices MEC
    Tape And Bandage, Adhesive KGX
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Regulator, Pressure, Gas Cylinder CAN
    Device, Fixation, Tracheal Tube CBH
    Holding Chambers, Direct Patient Interface NVP
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Support, Patient Position CCX
    Mask, Oxygen BYG
    Stylet, Tracheal Tube BSR
    Catheter And Tip, Suction JOL
    Protector, Skin Pressure FMP
    Mask, Gas, Anesthetic BSJ
    Apparatus, Suction, Single Patient Use, Portable, Nonpowered GCY
    Cushion, Wheelchair IMP
    Filter, Bacterial, Breathing-Circuit CAH

    Proprietary Names

    Sunset Portable Suction Machine Nebulizer Kit GuideBlade Sample Kit Sunset Strap Sunset Finger Pulse Oximeter Sunset Fingertip Pulse Oximeter with OLED Display Sunset Advanced Finger Pulse Oximeter HEPA Filter for 3B Stratus 5 Sunset Healthcare Respiratory Filter Sunset Lancet Aerosol Mask Sunset CPAP Tube Cleaning Brush Sunset O2 Meter Pediatric Nasal CPAP Mask Kit with S/M Cushions Sunset Healthcare CPAP Machine Pediatric Nasal CPAP Mask Headgear Pediatric Full Face CPAP Mask Pediatric Nasal CPAP Mask Cushion Replacement Pediatric Nasal CPAP Mask Kit with L/XS Adult Cushions Pediatric Full Face CPAP Mask Headgear Pediatric Full Face CPAP Mask Cushion Replacement Oxygen Mask Christmas Tree Connector Sunset Healthcare Solutions 800cc Suction Canister Sunset Healthcare Aerosol Bag Sunset Passive Heated Breathing Circuit Sunset Portable Nerve Stimulator Sunset Oxygen Cylinder Cart Sunset Healthcare Breathing Circuit Silicone Tubing FireSafe Cannula Valve Sunset Wheelchair Lumbar Cushion Sunset Breast Pump Disposable NIV Mask Sunset Healthcare CPAP Tubing Sunset Suction Canister Sunset Healthcare Oxygen Cannulas Sunset Capillary Tube Sunset Airway CPAP Cleaning wipes Sunset Coban Tape Roll Sunset Healthcare Breathing Tube Sunset Handheld Mesh Nebulizer Oxygen Regulator Sunset Healthcare Oxygen Cylinder Sunset Secure Cannula Stickers SperaChamber HME Filter Headgear Sunset Healthcare Oxygen Mask Sunset Intubating Stylet Suction Connecting Tube Sunset Nasal Gel Pad Sunset Healthcare Aerosol Mask, Anesthetic Mask Elbow Connector Sunset Wheel Chair Cushion Bacteria Filter

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)