Resp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant

GUDID 00840117345256

Tubing, 600 mL Reservoir Bag, Universal Connector

Dynarex Corporation

Non-rebreathing oxygen face mask
Primary Device ID00840117345256
NIH Device Record Key467a5ff5-a182-4372-8f03-94405979eecf
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Non-Rebreather Elongated Mask, Pediatric, 7' (2.1m) Crush-Resistant
Version Model Number33053U
Company DUNS008124539
Company NameDynarex Corporation
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117345195 [Package]
Package: Case [50 Units]
In Commercial Distribution
GS100840117345256 [Primary]

FDA Product Code

KGBMask, Oxygen, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-09
Device Publish Date2025-05-30