BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sunset Healthcare Solutions Central Warehouse

    Reg #: 3010834934 · FEI: 3010834934 · Expires 2026
    View on FDA
    Products
    51
    Proprietary Names
    65
    Establishment Types
    5
    Classifications
    51

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    Registration Details

    Registration Name
    Sunset Healthcare Solutions Central Warehouse
    Registration Number
    3010834934
    FEI Number
    3010834934
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2725 Alft Lane
    City
    Elgin
    State
    IL
    ZIP
    60124
    Country
    US

    Regulatory Submissions

    510(k) Number
    K222376

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

    Proprietary Names

    Sunset Lancet Sunset Strap Aerosol Mask Sunset Healthcare Oxygen Mask Oxygen Kit Sunset Handheld Mesh Nebulizer Sunset Passive Heated Breathing Circuit Sunset Humidifier Sunset Healthcare Aerosol Mask, Anesthetic Mask 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 Sunset Breast Pump HME Filter TUB06HPR Heated CPAP Tube Sunset Intubating Stylet Sunset Healthcare Oxygen Cannulas Elbow Connector Suction Connecting Tube Sunset Capillary Tube Nebulizer Kit Sunset Oximeter Disposable NIV Mask HEPA Filter for 3B Stratus 5 Sunset Healthcare Respiratory Filter Silicone Tubing Sunset Wheelchair Lumbar Cushion SperaChamber Sunset Resevoir Bag Sunset Finger Pulse Oximeter Sunset Fingertip Pulse Oximeter with OLED Display Sunset Advanced Finger Pulse Oximeter Sol Full Face CPAP Mask; Sol Full Face CPAP Mask Cushion Sunset Tubing Sunset Airway Sunset Secure Cannula Stickers Sunset Healthcare Aerosol Bag Sunset Fiber Sunset O2 Meter Oxygen Regulator Sunset Healthcare Oxygen Cylinder CPAP Cleaning wipes Christmas Tree Connector GuideBlade Sample Kit FireSafe Cannula Valve Sunset Healthcare Breathing Tube Sunset Wheel Chair Cushion Sunset Oxygen Cylinder Cart Sunset Healthcare Breathing Circuit Sunset Nasal Gel Pad Oxygen Mask Sunset Suction Canister Headgear Sunset Coban Tape Roll Sunset Healthcare Solutions 800cc Suction Canister Sunset Portable Nerve Stimulator Sunset CPAP Tube Cleaning Brush Bacteria Filter Sunset Portable Suction Machine Sunset Healthcare CPAP Tubing

    Establishment Types

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