Resp-O2 Compact Compressor Nebulizer

GUDID 00840117308718

DYNAREX CORPORATION

Nebulizing system, non-heated
Primary Device ID00840117308718
NIH Device Record Keydc6b717b-c1fe-4af3-a630-f1ede99190b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Compact Compressor Nebulizer
Version Model Number34401
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117308718 [Primary]
GS100840117308725 [Package]
Package: Case [6 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 Date2022-05-19
Device Publish Date2022-05-11

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