Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006446479

FEI Number

3006446479

Entity Name

SUNSET HEALTHCARE SOLUTIONS, Inc.

City/State/Country

CHICAGO, IL, US

Establishment Address

141 W Jackson Blvd Ste 1950, CHICAGO, IL 60604, US

Establishment Type(s)

Repack or Relabel Medical Device

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 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2019-09-26
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-09-20
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-12-05
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2012-05-01
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2017-01-04
JRL	Unit, Filter, Membrane	Clinical Chemistry	Class 1	862.2050	2008-01-10
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-12-16
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2014-07-17
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2017-12-04
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2017-12-04
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-07-27
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2009-03-31
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2014-02-21
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-09-14
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2013-04-01
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2021-02-03
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2017-09-12
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2017-12-04
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2011-01-21
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2014-07-17
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2015-05-19
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-12-04
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2017-12-04
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-06-25
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-07-27
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2017-12-04
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-04-01
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2025-12-05
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2009-03-24
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2019-12-30
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2025-12-05
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2009-12-16
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2022-08-10
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2010-08-15
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2017-12-04
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2020-06-04
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2011-02-07

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
3010834934	Sunset Healthcare Solutions Central Warehouse	Elgin, IL, US
3021244152	SUNSET HEALTHCARE SOLUTIONS Warehouse	Phoenix, AZ, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K812750	Instrumentation Laboratory CO	IL 703, STAT SEPARATOR	1982-01-26
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006446479. Last updated year: 2026. Please use registration number 3006446479 when referencing this establishment in official correspondence.