CPAP Headgear

GUDID 00848530085902

Replacement Headgear for Sunset Nasal Pillow Mask

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable
Primary Device ID00848530085902
NIH Device Record Keya794e74f-c028-49b5-9b1f-3f83a8a06b6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCPAP Headgear
Version Model NumberHG036
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530085902 [Primary]

FDA Product Code

BTKStrap, Head, Gas Mask

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-11-20
Device Publish Date2025-11-12

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530085902 - CPAP Headgear2025-11-20Replacement Headgear for Sunset Nasal Pillow Mask
00848530085902 - CPAP Headgear2025-11-20 Replacement Headgear for Sunset Nasal Pillow Mask
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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

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