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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 18 of 52
DeviceModel / ReferenceRegistriesClassStatus
CPAP Filter CF1009-1
FDA UDI
Class IActive
CPAP Filter ASAN011CF1010F-1
FDA UDI
Class IActive
Oxygen Tubing Connectors - Swivel RES018
FDA UDI
Class IActive
CPAP Kit MCT02
FDA UDI
Class IActive
Oxygen Kit ABAR003O2KIT
FDA UDI
N/AActive
CPAP Tubing ABAY015TUB0018PL
FDA UDI
Class IActive
Deluxe Nasal CPAP Mask with Removable Cushion - Large CM006L
FDA UDI
Class IIActive
Cough Assist Kit CAKIT002
FDA UDI
Class IIActive
Suction Kit TRAKIT8-D
FDA UDI
Class IIActive
CPAP Masks ASCM002CM036
FDA UDI
N/AActive
Standard Closed Suction System VEN46001600
FDA UDI
Class IActive
CPAP Filter CF101130DPL
FDA UDI
Class IActive
CPAP Filter CF5004-12
FDA UDI
Class IActive
Closed Suction VEN367100AM
FDA UDI
Class IActive
TRACHEOSTOMY and SUCTION ACCESSORY AOP904GS
FDA UDI
Class IActive
Cannula RES1107SZ
FDA UDI
Class IActive
Soft Adult Cannula without Tubing RES1100S
FDA UDI
Class IActive
Anesthesia AET3065C
FDA UDI
Class IActive
CPAP Mask CUCM207S
FDA UDI
Class IIActive
Mask for SperaChamber Size Large (Adult) RES195MASK-L
FDA UDI
Class IActive
Healthdyne Quest Style Foam Filter CF3003F-1
FDA UDI
Class IActive
Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters CF1005
FDA UDI
Class IActive
Nebulizer and Compressor NEB100NC
FDA UDI
Class IIActive
Oxygen Kit ASLE015O2KIT
FDA UDI
N/AActive
CPAP Filter CF9002NS
FDA UDI
Class IActive
CPAP Filter CF5004-1PL
FDA UDI
Class IActive
Oxygen Accessory RP039
FDA UDI
Class IActive
Oxygen Kit RES010VAKIT
FDA UDI
N/AActive
Cannula HFN001AM
FDA UDI
Class IActive
Fisher & Paykel HC230-HC600 Series Style Filters CF4002-2
FDA UDI
Class IActive
Tracheostomy and Suction Accessory TRAA004P
FDA UDI
Class IIActive
CPAP Filter CF2107-12
FDA UDI
Class IActive
CPAP Filter APAR008CF1009NT-12
FDA UDI
Class IActive
CPAP Filter ACPA052TUB006SSLIM
FDA UDI
Class IActive
Oxygen Tube ARES110RES3025-5
FDA UDI
Class IActive
Oxygen Kit ABAY002RES010KIT
FDA UDI
N/AActive
Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 5/Pack BF2200
FDA UDI
Class IIActive
Oxygen Kit R025101Ea
FDA UDI
N/AActive
CPAP Filter CF9003F-1PL
FDA UDI
Class IActive
Oxygen Liter Meter - 0-8 Liter/Minute RES034
FDA UDI
Class IIActive
Invacare Platinum Kit OF9002SP
FDA UDI
N/AActive
ResMed Sullivan VPAP Style Foam and Poly Filter Sets CF2101
FDA UDI
Class IActive
CPAP Filter AVIT007CF1006F-1PL
FDA UDI
Class IActive
Repair Parts RP017
FDA UDI
Class IActive
CPAP Filter CF2102-2PL
FDA UDI
Class IActive
Mini CGA 540 style O2 Regulator; 0-15 LPM RES045
FDA UDI
Class IActive
Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in) RES030P-14
FDA UDI
Class IActive
CPAP Filter CF5004PL
FDA UDI
Class IActive
CPAP Filter CF3003F-1PL
FDA UDI
Class IActive
Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters CF1005-1
FDA UDI
Class IActive

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