ResMed AirSense 11 Compatible Hypoallergenic Filters

GUDID 10848530102002

ResMed S11HA: 20 hypoallergenic filters

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, single-use
Primary Device ID10848530102002
NIH Device Record Key3cf015a4-b221-4026-9dbf-ef6162bbf614
Commercial Distribution StatusIn Commercial Distribution
Brand NameResMed AirSense 11 Compatible Hypoallergenic Filters
Version Model NumberAUSE001S11HA-20
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count20
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
Phone877-578-6738
Emailcustomerservice@sunsethcs.com
Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530102005 [Primary]
GS110848530102002 [Unit of Use]

FDA Product Code

JRLUnit, Filter, Membrane

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-20
Device Publish Date2024-03-12

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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
10848530108158 - Regulator2026-02-03 Standard CGA 870 Regulator, 1 DISS, 0-25LPM - BULK
00848530108304 - Repair Parts2026-02-03 Attendant/Direct Supply Cabinet with Door - 2/BX
10848530108226 - REPAIR PART2026-01-27 Drive Capacitor SSP 5 Liter (OEM# 525D-616)
00848530108236 - REPAIR PARTS2026-01-27 Drive Power Cord Strap (OEM# MC29D-657) - 10/PK

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