Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021244152

FEI Number

3021244152

Entity Name

SUNSET HEALTHCARE SOLUTIONS Warehouse

City/State/Country

Phoenix, AZ, US

Establishment Address

6750 West Van Buren St., Phoenix, AZ 85043, 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

K151461

PMA Number

N/A

All Registered Proprietary Names

Sol Full Face CPAP Mask; Sol Full Face CPAP Mask Cushion Sunset Secure Cannula Stickers Headgear Christmas Tree Connector Sunset Healthcare Breathing Circuit Elbow Connector Sunset Healthcare Solutions 800cc Suction Canister Sunset Wheelchair Lumbar Cushion Sunset Healthcare CPAP Tubing Sunset Oxygen Cylinder Cart Silicone Tubing Nebulizer Kit Sunset Oximeter CPAP Cleaning wipes Sunset Capillary Tube Sunset Finger Pulse Oximeter Sunset Fingertip Pulse Oximeter with OLED Display Sunset Advanced Finger Pulse Oximeter Sunset Healthcare Breathing Tube Sunset Portable Suction Machine Sunset Strap Sunset Portable Nerve Stimulator Sunset Lancet Sunset Healthcare Aerosol Bag SperaChamber Aerosol Mask Sunset Healthcare Oxygen Mask Sunset Breast Pump Sunset Humidifier Sunset Healthcare Oxygen Cannulas Sunset CPAP Tube Cleaning Brush TUB06HPR Heated CPAP Tube HME Filter Sunset O2 Meter Sunset Fiber Sunset Airway Sunset Passive Heated Breathing Circuit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2021-12-21
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2017-12-04
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2013-08-12
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2014-02-21
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2011-01-21
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2013-11-04
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-09-14
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2017-12-04
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2010-07-27
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2017-12-04
GAZ	Tubing, Noninvasive	General Hospital	Class 2	880.6740	2014-07-17
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2013-09-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-11-17
MEC	Disinfector, Medical Devices	General Hospital	Class 2	880.6992	2019-12-30
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2025-12-05
OCH	Oximeter, Infrared, Sporting, Aviation	Cardiovascular	Class 2	870.2700	2017-01-04
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2009-12-16
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2019-09-26
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2012-05-01
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2017-09-12
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2025-12-16
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2013-04-01
NVP	Holding Chambers, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2020-06-04
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2009-03-31
HGX	Pump, Breast, Powered	Obstetrics/Gynecology	Class 2	884.5160	2017-12-04
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2009-03-31
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2009-04-01
EPE	Brush, Cleaning, Tracheal Tube	Anesthesiology	Class 1	868.5795	2017-12-04
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2021-06-29
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2011-02-07
BXY	Flowmeter, Calibration, Gas	Anesthesiology	Class 1	868.2350	2017-12-04
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2012-04-25
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2009-03-24
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2021-02-03

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
3006446479	SUNSET HEALTHCARE SOLUTIONS, Inc.	CHICAGO, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K910471	Baxter Healthcare Corp	MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE	1991-03-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0033-04	VIASYS Med Systems	1	Neonatal/Infant Hyperinflation Circuit, consisting of a 0.5 L breathing bag, pressure monitoring tube with Bird adapter, oxygen supply tubing, sideport connector with adjustable bleed valve, and 40 cm H2O Popoff elbow; Mfg. for Corpak MedSystems, Wheeling, IL 60090; 20 units per case; reorder #BLD-83124-2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021244152. Last updated year: 2026. Please use registration number 3021244152 when referencing this establishment in official correspondence.