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SUNSET HEALTHCARE SOLUTIONS, Inc.

US

Last updated September 17, 2026

What SUNSET HEALTHCARE SOLUTIONS, Inc. makes

Sunset Healthcare Solutions, Inc. manufactures reusable and single-use respiratory filters for CPAP/BPAP units, including ambient air filters and anesthesia conduction filters, as well as reusable and single-use inspiratory/expiratory limb respiratory tubing. The company also produces CPAP/BPAP face masks, oxygen administration kits, closed-suction breathing circuit connectors, and tracheostomy ties. Additional products include circuit connectors, convenience kits, and specialized filters for anesthesia and ventilator use.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Sunset Healthcare Solutions, Inc. is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Sunset Healthcare Solutions, Inc. manufacture?

Sunset Healthcare Solutions, Inc. specializes in respiratory care devices. Their product line includes reusable and single-use components like CPAP/BPAP ambient air filters (both reusable and disposable), anesthesia conduction filters, inspiratory/expiratory limb respiratory tubing (reusable and single-use), CPAP/BPAP face masks (reusable), oxygen administration kits, closed-suction breathing circuit connectors, and tracheostomy ties. These devices are designed to support respiratory therapy, anesthesia, and ventilator applications.

Where is Sunset Healthcare Solutions, Inc. based?

Sunset Healthcare Solutions, Inc. is headquartered in the United States. The company’s location in the U.S. aligns with regulatory frameworks like the FDA’s UDI database, where its devices are listed for traceability and compliance purposes.

Which regulatory registries or databases list Sunset Healthcare Solutions, Inc.’s devices?

Sunset Healthcare Solutions, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is used to track medical devices throughout their lifecycle, ensuring transparency in identification, regulatory compliance, and supply chain management.

How are Sunset Healthcare Solutions, Inc.’s devices classified under FDA regulations?

Sunset Healthcare Solutions, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
141 W Jackson Blvd Ste 1950, CHICAGO, IL, 60604
Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3006446479
DUNS Number
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Catalogue (2582)

Page 20 of 52
DeviceModel / ReferenceRegistriesClassStatus
Oxygen Masks SBC01S
FDA UDI
Class IActive
Respironics Solo, Aria LX, Virtuoso LX, REMstar LX Style Ultrafine Filters CF1002-2
FDA UDI
Class IActive
Combo Pack CF5004Combo-2
FDA UDI
Class IIActive
Regulators/Conservers RES044PL
FDA UDI
Class IActive
Oxygen Filter OF9004NS
FDA UDI
Class IActive
CPAP Filter CF8005F-6PL
FDA UDI
Class IActive
3/16in Suction Tubing — 20in RES025-31620
FDA UDI
Class IIActive
Wheelchair Cushions WCL18
FDA UDI
Class IActive
CPAP Filter CF2107-5PL
FDA UDI
Class IActive
CPAP Kit AISI001CM006S
FDA UDI
N/AActive
AEIOMed Everest Aura, Everest III and Integrated Style Foam Filters CF8001-50
FDA UDI
Class IActive
CPAP Masks ALIF014CM205S
FDA UDI
N/AActive
Suction Kit AMED114TRACHKIT
FDA UDI
N/AActive
CPAP Tubing 100' Coil 22mm Tube with 6" Segments TUB100-6
FDA UDI
Class IActive
Oxygen Tubing Swivel Connector Kit RES018KIT-1
FDA UDI
Class IActive
CPAP Filter CF1006F-1PL
FDA UDI
Class IActive
CPAP Masks CM041LC-1
FDA UDI
Class IIActive
CPAP Filter ATEX002CF2111-6
FDA UDI
Class IActive
CPAP Filter CF1009PLC
FDA UDI
Class IActive
Suction Tubing VEN46011400
FDA UDI
Class IActive
CPAP Filter CF2107HA-12
FDA UDI
Class IActive
CPAP Filter CF2111-2PLC
FDA UDI
Class IActive
CPAP Filter CF1012F
FDA UDI
Class IActive
CPAP Filter CF1012-2PL
FDA UDI
Class IActive
Suction Kit RES026
FDA UDI
N/AActive
CPAP Tube 6ft TAGTD18
FDA UDI
Class IActive
CPAP Masks CM205MNH
FDA UDI
Class IIActive
Anesthesia AET4055C
FDA UDI
Class IActive
CPAP Filter CF1006FNS
FDA UDI
Class IActive
Oxygen Kit AFLO002O2KIT
FDA UDI
N/AActive
Resuscitation Kit RES8100HNS
FDA UDI
Class IActive
Oxygen Kit ABAR003RESUPPLY
FDA UDI
N/AActive
CPAP Filter AVIT007CF1007F-2PL
FDA UDI
Class IActive
Universal Headgear HG003
FDA UDI
Class IActive
Airsep Newlife, Newlife Elite Style Foam Cabinet Filter OF8002-1
FDA UDI
Class IActive
CPAP Mask CM061S-10
FDA UDI
Class IIActive
CPAP Filter CF5003
FDA UDI
Class IActive
FireSafe Cannula Kit AMRS001FiresafeKit
FDA UDI
Class IActive
Fisher & Paykel ICON Style Filters CF4003
FDA UDI
Class IActive
CPAP Mask CUCM206M
FDA UDI
Class IIActive
CPAP Filter PL-AIR11F
FDA UDI
Class IActive
Oxygen Kit ADSM001O2KITA
FDA UDI
Class IActive
Adult Cannula with 7ft Supply Tube - with Ear Cushions RES1107EC
FDA UDI
Class IActive
Oxygen Kit CAKIT004M
FDA UDI
Class IActive
React Regulator Valve RP073
FDA UDI
Class IActive
Washers with Rubber Ring - Aluminum RES036
FDA UDI
Class IIActive
CPAP Mask HG061S
FDA UDI
Class IIActive
Closed Suction VEN365120M
FDA UDI
Class IActive
Suction Component Kit BF516TSKIT
FDA UDI
Class IIActive
Respiratory Accessory TRAA003KIT
FDA UDI
N/AActive

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