Dynarex My Resp-O2 Bear Compressor Nebulizer

GUDID 00840117308732

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00840117308732
NIH Device Record Key7ce1d463-3106-4a06-a5f0-31c7bd0948df
Commercial Distribution StatusIn Commercial Distribution
Brand NameDynarex My Resp-O2 Bear Compressor Nebulizer
Version Model Number34002
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
GS100840117308732 [Primary]
GS100840117308749 [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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00840117341210 - Medicine Cups 1oz 2024-11-05

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