Handheld Compressor Nebulizer

GUDID 00848530099497

Handheld Compressor Nebulizer - Compressor Unit Only

SUNSET HEALTHCARE SOLUTIONS, INC.

Benchtop nebulizer, non-heated
Primary Device ID00848530099497
NIH Device Record Key46127bd6-2afb-4180-b273-5c2629e84bf2
Commercial Distribution StatusIn Commercial Distribution
Brand NameHandheld Compressor Nebulizer
Version Model NumberNEB200A
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530099497 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-03-13
Device Publish Date2024-03-05

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530108618 - CPAP Filter2026-03-27 Replacement Reusable Foam Filter 2/pkg ResPlus Oxygo AutoPAP Machine
00848530108632 - CPAP Tubing2026-03-27 Premium CPAP Tube, Rubber Cuffs, Gray, 8 ft.
00848530108472 - Oxygen, Bacteria & HEPA Filter2026-03-25 Invarecare 50PSI Foam Inlet Filter - 10/PK
00848530108489 - CPAP Filter2026-03-25 Filter, USA, AirSense 11, Standard 12 per pack
10848530108646 - Repair Parts2026-03-25 Heat Exchanger Assembly for Perfecto2 and Perfecto2V
00848530108656 - Repair Parts2026-03-25 Invacare Platinum 10L Flow Meter
10848530108660 - Repair Parts2026-03-25 Sieve Everflo Muffler Insulation
10848530108677 - Repair Parts2026-03-25 P2 Compressor Rebuild Kit with Top End and Bottom Flapper Assembly + Cup and Sleeve
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.