Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit NEB100

GUDID 00848530087326

Sunset Compressor Nebulizer w/ Disposable Adult Neb Kit

SUNSET HEALTHCARE SOLUTIONS, INC.

Nebulizing system delivery set, reusable
Primary Device ID00848530087326
NIH Device Record Key9eee3ebf-00bb-483c-8bd5-6fbe2f27ef69
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Compressor Nebulizer w/ Disposable Adult Neb Kit
Version Model NumberNEB100
Catalog NumberNEB100
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 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

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
GS100848530087326 [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 Date2018-10-22
Device Publish Date2018-09-21

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530107277 - Oxygen Kit2025-08-29 Oxygen Kit - This kit contains: RES1107S (4), RES3025G (2), RES037 (2), RES018 (2), RES003 (2), RES050 (2), and RES002 (1)
00848530104993 - RESUSCITATION KIT2025-08-28 Sunset Resuscitator, Adult, w/ Pop-Off, No Mask - 12pcs
00848530105006 - RESUSCITATION ACCESSORY2025-08-28 Sunset Disposable PEEP Valve, 5-20cm H20, 15mm ID
00848530105013 - RESUSCITATION ACCESSORY2025-08-28 Sunset Disposable Pressure Manometer, L-Shape - 25PCS
00848530105037 - RESUSCITATION KIT2025-08-28 Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter This kit contains: 1 RES8100H, 1SBC01M, 1SBC01L, RES8205B
00848530105044 - RESUSCITATION KIT2025-08-28 Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit contains: 1 RES8110H, 1 SBC01S, 1S
10848530107243 - Oxygen Connector/Adapter2025-08-27 Sunset Step-Down Tubing Adaptor 5-9mmOD; 22mmID
10848530107281 - Heat Moisture Exchanger2025-08-27 Sunset Adult In-line Large Volume HME with Gas Sampling Port

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.