ATCN-1

GUDID 00848530096151

Direct Supply Attendant Compressor Nebulizer

SUNSET HEALTHCARE SOLUTIONS, INC.

Benchtop nebulizer, non-heated
Primary Device ID00848530096151
NIH Device Record Key1fe38737-137b-46b4-81db-8ac1f5eefd62
Commercial Distribution StatusIn Commercial Distribution
Brand NameATCN-1
Version Model NumberATCN-1
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530096151 [Primary]

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-28
Device Publish Date2024-06-20

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530108168 - Regulators2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM
10848530108172 - CPAP Accessory2026-02-10 Sunset Nasal Gel Pad - 5/PK
00848530108267 - Filter - Vent2026-02-10 Luisa Gross Particle Internal Filter - 1/PK
10848530108271 - CPAP Tubing2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System
00848530108298 - CPAP Filter2026-02-04 Filter, USA, Standard S9, AirSense 10, AirCurve, 2/pack
00848530107932 - Nebulizer and Compressor2026-02-03 Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit
10848530108127 - Regulator2026-02-03 Standard CGA 870 Regulator, 1-DISS, 0-25LPM
00848530108137 - CPAP Filter2026-02-03 Filter, USA, Airsense 11, Standard, 50/Pack

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.