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.

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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

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