Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010834934

FEI Number

3010834934

Entity Name

Sunset Healthcare Solutions Central Warehouse

City/State/Country

Elgin, IL, US

Establishment Address

2725 Alft Lane, Elgin, IL 60124, US

Establishment Type(s)

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

Owner / Operator

Sunset Healthcare Solutions (Owner Number: 9106379)

Owner / Operator Contact Address

141 West Jackson Boulevard, 1950, Chicago, IL 60604, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-12-16
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2012-05-01
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2009-03-31
OGL	Oxygen Administration Kit	Anesthesiology	Class 2	868.5655	2022-09-20
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-08-10
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2021-02-03
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2009-03-31
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2010-07-27
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-07-27
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2017-12-04
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2011-02-07
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2021-06-29
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2025-12-05
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-04-01
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2013-11-04
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2014-07-17
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2025-12-05
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-09-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-11-17
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-06-25
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2008-01-10
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2014-07-17
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-12-04
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2020-06-04
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2009-03-26
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2017-01-04
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2021-12-21
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2013-01-04
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2009-03-24
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2017-12-04
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2013-04-01
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-04-25
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2017-12-04
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2010-08-15
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2019-12-30
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2014-02-21
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-05
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2015-05-19
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2009-12-16
IMP	Cushion, Wheelchair	Physical Medicine	Class 1	890.3920	2015-03-18
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2017-12-04

Official Correspondent

JOSEPH CONSOLI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sunset Healthcare Solutions

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3021244152	SUNSET HEALTHCARE SOLUTIONS Warehouse	Phoenix, AZ, US
3006446479	SUNSET HEALTHCARE SOLUTIONS, Inc.	CHICAGO, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010834934. Last updated year: 2026. Please use registration number 3010834934 when referencing this establishment in official correspondence.