Sunset Healthcare Solutions Inc

FDA Filings

This page includes the latest FDA filings for Sunset Healthcare Solutions Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Sunset Healthcare Solutions Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3006446479
FEI Number3006446479
NameSUNSET HEALTHCARE SOLUTIONS, Inc.
Owner & OperatorSunset Healthcare
Contact Address180 N Michigan Ave #2000
Chicago IL 60601 US
Official Correspondent
  • Nazree - Williams
  • x-312-5332457-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address180 N Michigan Ave Ste 2000
CHICAGO, IL 60601 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
SUNSET HEALTHCARE SOLUTIONS, INC.
Two Piece Tracheostomy Tie Pediatric 2cm x 45.5cm (18in) 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in) 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in) 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in) 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in) 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in) 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Löwenstein LUISA Ventilator and prisma Style Reusable CPAP Filter 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Celon Wet Bands 66 x 120mm 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Celon Wet Bands 30.5 x 40mm 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Celon Wet Bands 30.5 x 25mm 2024-03-28
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed S9 and AirSense 10 Compatible Hypoallergenic Filters 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed S9 and AirSense 10 Compatible Disposable Filters 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed AirSense 11 Compatible Hypoallergenic Filters 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed AirSense 11 Compatible Disposable Filters 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed AirMini Compatible Disposable Filters 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
DreamStation 2 Kit: 2 reusable, 6 disposable 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
DreamStation 2 Kit: 4 reusable, 20 disposable 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
DreamStation 1 Kit: 2 reusable, 6 disposable 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
DreamStation 1 Kit: 4 reusable, 20 disposable 2024-03-20
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed AirSense 11 Style Filters 2024-03-19
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed S9 and AirSense 10 Style Filters 2024-03-19
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics DreamStation 2 Style Reusable Filters 2024-03-19
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics DreamStation 2 Style Disposable Filters 2024-03-19
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics DreamStation Style Reusable Filters 2024-03-19
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics DreamStation Style Disposable Filters 2024-03-19
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Portable Suction Machine with AC/DC Power 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Respironcis Triology EV300 Reusable Filter 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Respironcis Triology EV300 Reusable Filter 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Mask for SperaChamber Size Small (Infant) 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Mask for SperaChamber Size Medium (Pediatric) 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Mask for SperaChamber Size Large (Adult) 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Handheld Compressor Nebulizer 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Heated CPAP Tube for DreamStation Series and PR System One 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Oxygen Cylinder Wrench for Tank Valve - 1/pk 2024-03-13
SUNSET HEALTHCARE SOLUTIONS, INC.
Resmed Airsense 11 CPAP Filter 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Resmed S9 & S10 CPAP Filter 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics DreamStation 2 Style Disposable Filter 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Reusable CPAP filter compatible with Respironics DreamStation 1 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics DreamStation Style Disposable Filters 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Philips Respironics Dream Station 2 Reusable Ultrafine Filter 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Nasal Mask with Standard Headgear, Small, Non-Vented Elbow 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
F&P Sleepstyle CPAP filter 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Nasal Mask with Standard Headgear, Large, Non-Vented Elbow 2024-03-12
SUNSET HEALTHCARE SOLUTIONS, INC.
3B Luna G3 CPAP Reusable Filter CF8006F-122024-03-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Ultra Fine Filter Compatible w/ Healthdyne Tranquility MPR CF3002-22024-03-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Resmed AirMini CPAP Filter CF2108-502024-03-06
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed S9 and AirSense 10 Style Filters CF2107-202024-02-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset 3B Luna G3 Style Ultrafine Filter CF8006-502024-02-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Heated CPAP Tube TUB06HPR-E2024-02-28
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Christmas Tree Connector – Non-Swivel RES001-502024-02-27
SUNSET HEALTHCARE SOLUTIONS, INC.
Direct Supply Attendant Oxygen Startup Kit 2024-02-05
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Nasal Pillow CPAP Mask - Small 2023-06-09
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Nasal Pillow CPAP Mask - Medium 2023-06-09
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Nasal Pillow CPAP Mask - Large 2023-06-09
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Nasal Pillow CPAP Mask - Small 2023-06-09
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Nasal Pillow CPAP Mask - Medium 2023-06-09
SUNSET HEALTHCARE SOLUTIONS, INC.
Deluxe Nasal Pillow CPAP Mask - Large 2023-06-09
SUNSET HEALTHCARE SOLUTIONS, INC.
Oxygen Kit 2022-12-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Heated CPAP Tube 2021-10-22
Sunset Healthcare Solutions, Inc.
Sunset Heated CPAP Tube2021-01-29
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large CUCM005L2020-07-24
SUNSET HEALTHCARE SOLUTIONS, INC.
Drawstring Bags 10in x 10in BAGDS10102020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Portable Suction Machine, Replacement Power Cord (without Adapter) SU100DC-Cord2020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Portable Suction Machine Replacement Power Adapter (without Cord) SU100DC-Adapt2020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Nasal CPAP Mask — Small CM006SPL2020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
CPAP Bedside Holder CAP10152020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Comfort Chinstrap CS0052020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Cylinder Wrenches for Tank Valve - Without Chain RES032-502020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Healthcare Solutions 800cc Suction Canister - 1/Case RES023-12020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Healthcare Solutions 800cc Suction Canister - 12/Case RES023-122020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Healthcare Solutions - Bemis - 800cc Suction Canister RES023-702020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Washers with Smooth Rubber Ring - Brass RES035SR2020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Washers with Rubber Ring - Brass RES035-502020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Washers with Rubber Ring - Aluminum RES0362020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Washer with Rubber Ring - Brass RES035-12020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Oxygen Liter Meter - 0-8 Liter/Minute RES0342020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Regular Yoke Washer - Brass RES0332020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Sunset Healthcare Solutions 800cc Suction Canister - 10/Case RES0232020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Oxygen In Use Signs RES0032020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed S9 and AirSense 10 Style Hypoallergenic Filters CF2107HA-22020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
ResMed S7 Style Hypoallergenic Filters CF2103HA2020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
6in HEPA Capsule with Removable Sticker BFH6S2020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
FILTER,HYDROPHOBIC, SET, BARB AGIBF4052020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Oxygen Tubing Y-Connector AGISH7492020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Washers with Rubber Ring - Brass HCS1668402020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Cylinder Wrenches for Post Valve AMED014RES0322020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Adapter, Pressure Line O2 Treatment HCS16422020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Christmas Tree Nut and Nipple Adaptor HCS45552020-05-06
SUNSET HEALTHCARE SOLUTIONS, INC.
Zoey CPAP Cleaner ZCD1002020-03-09
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Zoey CPAP Cleaner2019-12-30
SUNSET HEALTHCARE SOLUTIONS, INC.
Carry Bag for Portable Suction Machine SU100DC-BAG2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Comfort Shoulder Bag for D Cylinders CSBD2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Bag for Compressor Nebulizer NEB100-BAG2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Cylinder Roller Bag & Backpack — Single D/E Tank CSBD1Roller2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Backpack for D Cylinders CSBDBP2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Flex O2 Bag CSBM6Flex2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Comfort Shoulder Bag for C/M9 Cylinders CSBM92019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Backpack for B/M6, C/M9 or Smaller Cylinders CSBM6BP2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Comfort Shoulder Bag for B/M6 Cylinders CSBM62019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Wheelchair/Scooter Carrier for E Cylinders CSBE2019-12-11
SUNSET HEALTHCARE SOLUTIONS, INC.
Wireless TENS TEN2002019-10-23
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Breast Pump2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Suction Canister2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Wheelchair Lumbar Cushion2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset CPAP Tube Cleaning Brush2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Secure Cannula Stickers2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Oxygen Cylinder Cart2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset O2 Meter2017-12-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Portable Nerve Stimulator2017-09-12
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Finger Pulse Oximeter (RES5100)2017-01-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Advanced Finger Pulse Oximeter (RES5101)2017-01-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
FireSafe Cannula Valve2015-05-19
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Wheel Chair Cushion2015-03-18
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Suction Connecting Tube2014-07-17
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Silicone Tubing2014-07-17
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Aerosol Mask2014-07-17
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Elbow Connector2013-11-04
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Headgear2013-08-12
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Strap2012-05-01
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare HME Filter2011-02-07
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
HME Filter2011-02-07
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Breathing Circuit2011-01-21
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Oxygen Cylinder2010-08-15
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare CPAP Machine2010-07-27
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare CPAP Tubing2010-07-27
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Aerosol Mask, Anesthetic Mask2010-07-27
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Breathing Tube2009-12-16
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
CPAP Tubing2009-12-16
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Oxygen Cannulas2009-04-01
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Oxygen Mask2009-03-31
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Oxygen Mask2009-03-31
SUNSET HEALTHCARE SOLUTIONS, Inc. [Sunset Healthcare]
Sunset Healthcare Respiratory Filter2008-01-10

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019121945957Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaHOMEFILL TUBING CONNECTOR HS CODE:3917.3945 CTN
2019121945954Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaHOMEFILL TUBING CONNECTOR HS CODE:3917.3980 CTN
2019121730689Shanghai ,China (Mainland) -> Long Beach, CaliforniaOXYGEN REGULATOR260 CTN
2019121732331Shanghai ,China (Mainland) -> Long Beach, CaliforniaOXYGEN REGULATOR115 CTN
2019121238820Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaHOMEFILL TUBING CONNECTOR HS CODE:3917.3930 CTN
2019112152098Kaohsiung,China (Taiwan) -> Los Angeles, CaliforniaHOMEFILL TUBING CONNECTOR HS CODE:3917.3980 CTN
201910315956Shanghai ,China (Mainland) -> Los Angeles, CaliforniaOXYGEN REGULATOR220 CTN
2019101620163Tsingtao,China (Mainland) -> Tacoma, WashingtonYANKAUER-VENTED127 CTN

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