Oxygen Masks

GUDID 10848530104228

Sunset Breathing Mask, No Hooks - Toddler

SUNSET HEALTHCARE SOLUTIONS, INC.

Aerosol face mask, rebreathing, single-use
Primary Device ID10848530104228
NIH Device Record Keye173c1df-e278-4890-b083-836b0ad53286
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxygen Masks
Version Model NumberSBC01T
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count20
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
GS100848530104221 [Primary]
GS110848530104228 [Unit of Use]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-09
Device Publish Date2024-08-01

On-Brand Devices [Oxygen Masks]

00848530104276Cough Assist Mouthpiece - Bulk
00848530096304Low Concentration Venturi Adapter
00848530096281Low Concentration Venturi Style Oxygen Delivery System
10848530104228Sunset Breathing Mask, No Hooks - Toddler
10848530104211Sunset Breathing Mask, No Hooks - Infant
10848530040311Sunset Breathing Mask, No Hooks - Adult Large
10848530040304Sunset Breathing Mask, No Hooks - Adult Medium
10848530040298Sunset Breathing Mask, No Hook s - Adult Small
00848530104221Sunset Breathing Mask, No Hooks - Toddler
00848530104214Sunset Breathing Mask, No Hooks - Infant
00848530040314Sunset Breathing Mask, No Hooks - Adult Large
00848530040307Sunset Breathing Mask, No Hooks - Adult Medium
00848530040291Sunset Breathing Mask, No Hook s - Adult Small

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