Resp-O2 Oxygen Concentrator, 5L

GUDID 00840117310254

DYNAREX CORPORATION

Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator 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

Devices Manufactured by DYNAREX CORPORATION

00840117335318 - Ridgewood Collection Home Care Bed Full Electric ( Deck )2024-05-13
00840117335325 - Ridgewood Collection Home Care Full Electric ( Board )2024-05-13
08401173287854 - DynaCare Tampons,Super,Plastic Applicator 2024-04-17 Unscented, Free of Dyes & Perfumes
00860008059512 - IV Start Kit2024-04-10
00840117333215 - Instant Cold Pack, 4" x 5" 2024-04-08 For use whenever instant cold therapy is required
00616784046617 - Homecare Half Length Bed Rail Cross Bar Mount2024-04-05
00616784706313 - IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic2024-04-02 15" , Sterile
00840117333000 - XeroBurn Sterile Burn Dressing Blanket 2024-04-02 30" x 35"

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.