REPAIR PART

GUDID 10848530104266

PE Valve for Invacare Platinum (IRC10LXO2, IRC5LXO2), Perfecto (IRC5PO2) and the PerfectoV (IRC5PO2V) #1143578

SUNSET HEALTHCARE SOLUTIONS, INC.

Mobile/portable oxygen concentrator
Primary Device ID10848530104266
NIH Device Record Key6169bedf-8fa7-4463-ba7e-e692e506bf45
Commercial Distribution StatusIn Commercial Distribution
Brand NameREPAIR PART
Version Model NumberRP003
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530104269 [Primary]
GS110848530104266 [Package]
Contains: 00848530104269
Package: [40 Units]
In Commercial Distribution

FDA Product Code

BYXTubing, Pressure And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-04
Device Publish Date2025-08-27

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530085902 - CPAP Headgear2025-11-20 Replacement Headgear for Sunset Nasal Pillow Mask
00848530107598 - CPAP Filters2025-11-20 Private Labeled" 3B Luna G3 and React G3X CPAP Reusable Filter - 2/Pack
00848530107604 - CPAP Filters2025-11-20 3B Luna and React G3X Replacement CPAP Filter - 6/Pack (in bags of 50)
00848530107611 - Replacement Part2025-11-20 Respironics Everflo SMC Pilot and Body Valve (OEM: 1111248/1111249)
10848530107625 - Replacement Part2025-11-20 LUISA, Astral, V*Home, and Trilogy O2 Quick Connect Straight Adapter, 1/4" Barb - 2/PK
00848530107635 - CPAP Filter2025-11-20 F&P Sleepstyle CPAP Filter - 6/PK
00848530107444 - O2 Starter Kit 2025-10-07 O2 Starter Kit - 1 Kit Contains: RES3025G(1), RES1107SHF(2), RES018NS(1), RES050(1), HUM008(1), RES037)1), RES2100(1), RES2102(
10848530107458 - Stratus Power Switch2025-10-02 Replacement Part for Stratus Power Switch - 25ea

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