Resmed S9 & S10 CPAP Filter

GUDID 10848530102736

Resmed S9 & S10 CPAP Filter - 3/Pack

SUNSET HEALTHCARE SOLUTIONS, INC.

Surgical suction system collection container, single-use
Primary Device ID10848530102736
NIH Device Record Key80daedc1-e2e1-47aa-84bb-6d323c50f296
Commercial Distribution StatusIn Commercial Distribution
Brand NameResmed S9 & S10 CPAP Filter
Version Model NumberCF2107E-3
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count3
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530102739 [Primary]
GS110848530102736 [Unit of Use]

FDA Product Code

GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-12
Device Publish Date2024-03-04

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.