Resp-O2 Oxygen Concentrator, 5L

GUDID 00840117310254

DYNAREX CORPORATION

Stationary oxygen concentrator
Primary Device ID00840117310254
NIH Device Record Key425bbb83-d00c-4af9-9417-32e95744be01
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 Oxygen Concentrator, 5L
Version Model Number33950
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
GS100840117310254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-18
Device Publish Date2022-05-10

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