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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 21 of 52
DeviceModel / ReferenceRegistriesClassStatus
Invacare Platinum Kit OF9002SP-A
FDA UDI
N/AActive
Respiratory Accessory RES019-CAP1
FDA UDI
Class IActive
Nebulizer Accessories NEB402-MP
FDA UDI
Class IIActive
Sunset Healthcare Solutions Pediatric Disposable Nebulizer Kit w/ Aerosol Mask RES092
FDA UDI
Class IIActive
Mini CGA 870 Style Regulator 0-4lpm Pediatric RES046
FDA UDI
Class IActive
CPAP Filter CF2111-12
FDA UDI
Class IActive
CPAP Filter AVIT007CF1010-2PL
FDA UDI
Class IActive
Nidek Nuvo Style Foam Cabinet Filters OF11003
FDA UDI
Class IActive
Sunset Flex HME RES027FLEX
FDA UDI
Class IActive
Suction Tubing VEN46011600
FDA UDI
Class IActive
CPAP Masks CM041SC
FDA UDI
Class IIActive
Anesthesia AET3004U
FDA UDI
Class IActive
Oxygen Filter OF6030NS
FDA UDI
Class IActive
Suction Kit RES026S-BPL
FDA UDI
N/AActive
Oxygen Accessory RES031BNS
FDA UDI
Class IIActive
Oxygen Kit AHER005O2KIT
FDA UDI
N/AActive
CPAP Masks CM041M-1
FDA UDI
Class IIActive
CPAP Filter ABAY015CF1009F-1PL
FDA UDI
Class IActive
CPAP Filter CF1010-3PL
FDA UDI
Class IActive
Breathing Circuit VC1000
FDA UDI
Class IIActive
Oxygen Kit RES03702KIT
FDA UDI
N/AActive
6Ft Light Gray Smoothbore CPAP Tubing - Slim Style TUB006SS
FDA UDI
Class IActive
CPAP Filter CF2106PL
FDA UDI
Class IActive
ResMed Sullivan VPAP Style Foam and Poly Filter Set CF2101-1
FDA UDI
Class IActive
Headgear HG060L
FDA UDI
Class IIActive
Anesthesia AET1045C
FDA UDI
Class IActive
3B RESmart Style Filters CF8004
FDA UDI
Class IActive
Repair Parts RP021
FDA UDI
Class IActive
CPAP Filter CF2105-6
FDA UDI
Class IActive
Celon Wet Bands 66 x 120mm WB66120
FDA UDI
Class IActive
Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Foam Filter CF1005F-1
FDA UDI
Class IActive
CPAP Kit TUB06CF8004-6PL
FDA UDI
N/AActive
CPAP Filter CF1007-50
FDA UDI
Class IActive
Evo Medical Comfort PAP, CareFusion PureSom, and ProBasics Zzz-Pap Style Foam CF9003F
FDA UDI
Class IActive
CPAP Filter CF6003NS
FDA UDI
Class IActive
CPAP Nasal Cushions ASCM002CM036LP
FDA UDI
Class IIActive
CPAP Filter ALAB002CF4004-2
FDA UDI
Class IActive
Deluxe Closed Suction System VEN161100A
FDA UDI
Class IActive
Covidien Nellcor Puritan Bennett GoodKnight 418 Style Foam Filters CF6001F-2
FDA UDI
Class IActive
CPAP Filter CM041MEEC
FDA UDI
Class IIActive
Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit NEB100-R
FDA UDI
Class IIActive
Repair Parts RP023
FDA UDI
Class IActive
Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Foam Filters CF1005F
FDA UDI
Class IActive
CPAP Filter ALAB002CF2111
FDA UDI
Class IActive
CPAP Filter CF1012-12PL
FDA UDI
Class IActive
Oxygen Kit AISL004O2KITBPL
FDA UDI
N/AActive
CPAP Kit AMED049Combo
FDA UDI
Class IActive
Suction Kit RES026S-EL10NT
FDA UDI
Class IActive
Flex O2 Bag CSBM6Flex
FDA UDI
Class IActive
CPAP Filter ASNU001CF1010-2
FDA UDI
Class IActive

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