Sunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow

GUDID 10848530101265

Sunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP nasal mask, reusable
Primary Device ID10848530101265
NIH Device Record Keybdd5effd-480d-4757-9254-ae743942bb8b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSunset Nasal Mask with Standard Headgear, Medium, Non-Vented Elbow
Version Model NumberCM008MVNV-10
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530101268 [Primary]
GS110848530101265 [Package]
Contains: 00848530101268
Package: [10 Units]
Discontinued: 2024-03-04
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2024-03-12
Device Publish Date2024-03-04

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530108168 - Regulators2026-02-10 Private Labeled - Standard CGA 870 Regulator, 1-DISS, 0-25LPM
10848530108172 - CPAP Accessory2026-02-10 Sunset Nasal Gel Pad - 5/PK
00848530108267 - Filter - Vent2026-02-10 Luisa Gross Particle Internal Filter - 1/PK
10848530108271 - CPAP Tubing2026-02-10 Adapter for Resmed S10 Heated CPAP Tube System
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

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