RespO2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag Oxygen

GUDID 00840117326002

Tubing, Peep Valve

DYNAREX CORPORATION

Pulmonary resuscitator, manual, single-use
Primary Device ID00840117326002
NIH Device Record Key38dc51d2-6dcb-477b-9c59-1ffcbe72bb55
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespO2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag Oxygen
Version Model Number36007
Company DUNS008124539
Company NameDYNAREX CORPORATION
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117326002 [Primary]
GS100840117326019 [Package]
Package: Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTMVentilator, Emergency, Manual (Resuscitator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-09-20
Device Publish Date2023-01-09

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