Adult Aerosol Mask RES2110

GUDID 10848530060975

Adult Aerosol Mask

SUNSET HEALTHCARE SOLUTIONS, INC.

Aerosol face mask, rebreathing
Primary Device ID10848530060975
NIH Device Record Keybe8c4c33-6e52-45e4-999e-824cb1ccced1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Aerosol Mask
Version Model NumberRES2110
Catalog NumberRES2110
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530060978 [Primary]
GS110848530060975 [Package]
Contains: 00848530060978
Package: [50 Units]
In Commercial Distribution

FDA Product Code

BYFMask, Oxygen, Low Concentration, Venturi

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-19

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530040291 - Oxygen Masks2024-08-23 Sunset Breathing Mask, No Hook s - Adult Small
00848530040307 - Oxygen Masks2024-08-23 Sunset Breathing Mask, No Hooks - Adult Medium
00848530040314 - Oxygen Masks2024-08-23 Sunset Breathing Mask, No Hooks - Adult Large
00848530104214 - Oxygen Masks2024-08-23 Sunset Breathing Mask, No Hooks - Infant
00848530104221 - Oxygen Masks2024-08-23 Sunset Breathing Mask, No Hooks - Toddler
10848530091290 - Power and Accessories2024-08-16 Portable Suction Machine DC Mobile Power Adapter
00848530091378 - Portable Suction2024-08-16 Portable Suction Machine AC
10848530091870 - Power and Accessories2024-08-16 Replacement Battery for SU100DC Portable Suction Machine

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.