Adult Simple Oxygen Mask w/7' Safety Tubing RES2100

GUDID 10848530060944

Adult Simple Oxygen Mask w/7' Safety Tubing

SUNSET HEALTHCARE SOLUTIONS, INC.

Rebreathing oxygen face mask
Primary Device ID10848530060944
NIH Device Record Key6813686b-2643-460e-b24c-80a56050447d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdult Simple Oxygen Mask w/7' Safety Tubing
Version Model NumberRES2100
Catalog NumberRES2100
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 Datetrue
Expiration Datefalse
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
GS100848530060947 [Primary]
GS110848530060944 [Package]
Contains: 00848530060947
Package: [50 Units]
In Commercial Distribution

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 Date2018-10-25
Device Publish Date2018-09-24