Vented CPAP Masks

GUDID 10848530108356

Sunset Adult Dual Limb Active Circuit

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP face mask, reusable
Primary Device ID10848530108356
NIH Device Record Key75cf53fc-a6e8-47fb-b56b-066510acd5dc
Commercial Distribution StatusIn Commercial Distribution
Brand NameVented CPAP Masks
Version Model NumberVC1009
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530108359 [Primary]
GS110848530108356 [Package]
Contains: 00848530108359
Package: [20 Units]
In Commercial Distribution

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-11
Device Publish Date2026-03-03

On-Brand Devices [Vented CPAP Masks ]

10848530108387Sunset Adult Dual Limb Active Circuit with Water Trap
10848530108370Sunset Pediatric Dual Limb Active Circuit with Water Trap
10848530108363Sunset Peditric Dual Limb Active Circuit
10848530108356Sunset Adult Dual Limb Active Circuit

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