Dynarex My Resp-O2 Penguin Compressor Nebulizer

GUDID 00840117308794

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00840117308794
NIH Device Record Key2687a339-26e6-404e-bde4-837682b59fcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynarex My Resp-O2 Penguin Compressor Nebulizer
Version Model Number34405
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100840117308794 [Primary]
GS100840117308800 [Package]
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-27
Device Publish Date2021-01-19

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