CPAP Filer

GUDID 00848530093051

Respironics DreamStation Ultra Fine Filter - 500 Pack

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, single-use
Primary Device ID00848530093051
NIH Device Record Keye224ff0b-7184-4e89-ad7f-c644152c727c
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPAP Filer
Version Model NumberCF1010-500
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
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

Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com
Phone8775786738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530093051 [Primary]

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 Date2024-07-25
Device Publish Date2024-07-17

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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00848530030605 - CPAP Filter2024-07-25 Respironics BiPAP Pro, Plus, Duet LX, Synchrony Style Ultrafine Filters Bulk
00848530031169 - CPAP Filter2024-07-25 Respironics M-Series Style Foam Filter - 1/Pack
00848530032845 - CPAP Filter2024-07-25 ResMed S9 and AirSense 10 Style Hypoallergenic Filters 1/Pack
00848530081201 - CPAP Filter2024-07-25 ResMed S9 and AirSense 10 Style Hypoallergenic Filters - 12/Pack
00848530081782 - Oxygen Kit2024-07-25
00848530082949 - CPAP Filter2024-07-25 Resmed S-9 CPAP Filter - 2/Pack - Private Labeled

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