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Data / Medical devices / United States / Sunset Healthcare Solutions Central Warehouse

Sunset Healthcare Solutions Central Warehouse: FDA-registered device maker in Elgin, IL, United States, 15 510(k) clearances

Sunset Healthcare Solutions Central Warehouse is registered with the FDA (registration 3010834934) in Elgin, IL, United States. It lists 53 device types. The FDA files 15 510(k) clearances under its listings, the newest dated October 3, 2022. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Sunset Healthcare Solutions Central Warehouse
FDA registration number
3010834934
Address
2725 Alft Lane, Elgin, IL, United States, 60124
Owner or operator
Sunset Healthcare Solutions (9106379)
Roles
Complaint file establishment, Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler
First device listed
January 10, 2008
Registered through
2027
Brand names listed
Aerosol Mask, Bacteria Filter, CPAP Cleaning wipes, Christmas Tree Connector, Cough Assist, Disposable NIV Mask, Elbow Connector, FireSafe Cannula Valve and more

Devices it lists

DeviceProduct codeClassRoleSource
Airway, Oropharyngeal, AnesthesiologyCAE1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Single Patient Use, Portable, NonpoweredGCY1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Ward Use, Portable, Ac-PoweredJCX2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Bag, ReservoirBTC1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Bandage, Liquid, Skin ProtectantNEC1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Bottle, Collection, VacuumKDQ2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Remanufactureraccessdata.fda.gov
Cart, Emergency, Cardiopulmonary (Excluding Equipment)BZN1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Repackager or relabeleraccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Repackager or relabeleraccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Repackager or relabeleraccessdata.fda.gov
Connector, Airway (Extension)BZA1Repackager or relabeleraccessdata.fda.gov
Cushion, WheelchairIMP1Repackager or relabeleraccessdata.fda.gov
Device, Fixation, Tracheal TubeCBH1Complaint file establishment, Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Device, Positive Pressure Breathing, IntermittentNHJ2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Disinfector, Medical DevicesMEC2Complaint file establishmentaccessdata.fda.gov
Drain, Tee (Water Trap)BYH1Repackager or relabeleraccessdata.fda.gov
Fiber, Medical, AbsorbentFRL1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Repackager or relabeleraccessdata.fda.gov
Flowmeter, Calibration, GasBXY1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure CompensatedCAX1Repackager or relabeleraccessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE2Complaint file establishment, Manufacturer, Repackager or relabeleraccessdata.fda.gov
Holding Chambers, Direct Patient InterfaceNVP2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)KFZ1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Knife, SurgicalEMF1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Repackager or relabeleraccessdata.fda.gov
Mask, OxygenBYG1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Repackager or relabeleraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Repackager or relabeleraccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Orthosis, LumbarIQE1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Oximeter, Infrared, Sporting, AviationOCH2Repackager or relabeleraccessdata.fda.gov
Oxygen Administration KitOGL2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Protector, Skin PressureFMP1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Pump, Breast, PoweredHGX2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Repackager or relabeleraccessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureFMK2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain ReliefGZJ2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Strap, Head, Gas MaskBTK1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Stylet, Tracheal TubeBSR1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Support, Patient PositionCCX1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Tape And Bandage, AdhesiveKGX1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Tube, Collection, Capillary BloodGIO1Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Tubing, NoninvasiveGAZ2Repackager or relabeleraccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Repackager or relabeleraccessdata.fda.gov
Unit, Filter, MembraneJRL1Complaint file establishment, Manufactureraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov
Ventilator, Non-Continuous (Respirator)BZD2Complaint file establishment, Repackager or relabeleraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 3, 2022K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)FMKSubstantially EquivalentShandong Lianfa Medical Plastic Products Co. , Ltd.accessdata.fda.gov
July 2, 2021K203347Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow MaskBZDSubstantially EquivalentSuzhou Yuyue Medical Technology Co., Ltd.accessdata.fda.gov
January 29, 2021K201418Sunset Heated CPAP TubeBZESubstantially EquivalentSunset Healthcare Solutions, Inc.accessdata.fda.gov
September 27, 2020K182906Portable Mesh NebulizerCAFSubstantially EquivalentFeellife Health, Inc.accessdata.fda.gov
March 24, 2016K151461Hybernite RTBZESubstantially EquivalentPlastiflex Group NVaccessdata.fda.gov
April 24, 2014K132882ELECTRIC BREAST PUMPHGXSubstantially EquivalentShantou Xinghe Electrical Apparatuses Co., Ltd.accessdata.fda.gov
December 14, 2012K121955COUGHASSIST T70 DEVICENHJSubstantially EquivalentRespironics, Inc.accessdata.fda.gov
July 27, 2012K113544ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGERGZJSubstantially EquivalentProspera Corporationaccessdata.fda.gov
September 13, 2011K102483SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104CAHSubstantially EquivalentSunset Healthcare Solutions, LLCaccessdata.fda.gov
August 12, 2011K102120NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202CBKSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov
January 28, 2011K101136FISIO CHAMBER SPACENVPSubstantially EquivalentKoo (Shanghai) Industries Co., Ltd.accessdata.fda.gov
November 12, 2010K102626VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01JCXSubstantially EquivalentVega Technologies, Inc.accessdata.fda.gov
November 10, 2009K091272BESMED JET NEBULIZER BOTTLE SETCAFSubstantially EquivalentBesmed Health Business Corpaccessdata.fda.gov
August 13, 2007K070371FINGERTIP PULSE OXIMETER MD300CDQASubstantially EquivalentBeijing Choice Electronic Technololgy Co., Ltd.accessdata.fda.gov
February 23, 2007K063268CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235BZDSubstantially EquivalentHsiner Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated October 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.