Resp-O2 Manual Pulmonary Resuscitator (MPR)

GUDID 00840117308343

Resp-O2 Infant Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing

DYNAREX CORPORATION

Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use Pulmonary resuscitator, manual, single-use
Primary Device ID00840117308343
NIH Device Record Key639cd398-6717-4da0-963d-c1ce002b2ea9
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Manual Pulmonary Resuscitator (MPR)
Version Model Number36005
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100840117308336 [Primary]
GS100840117308343 [Package]
Contains: 00840117308336
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-30
Device Publish Date2021-04-22

On-Brand Devices [Resp-O2 Manual Pulmonary Resuscitator (MPR)]

00840117313965Resp-O2 Infant Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Tubing, Oxygen Tubing
00840117313941Resp-O2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Tubing, Oxygen Tubing
00840117313927Resp-O2 Adult Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing, PEEP Valve
00840117308404Resp-O2 Adult Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing
00840117308381Resp-O2 Adult Manual Pulmonary Resuscitator Mask (MPR), Reservoir tubing, Oxygen Tubing
00840117308367Resp-O2 Pediatric Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing
00840117308343Resp-O2 Infant Manual Pulmonary Resuscitator (MPR) Mask, Reservoir Bag, Oxygen Tubing

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