Resp-O2 10L Oxygen Concentrator

GUDID 00840117342736

Dynarex Corporation

Mobile/portable oxygen concentrator
Primary Device ID00840117342736
NIH Device Record Key1da87489-6cc4-478d-a683-74657adb6b96
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2 10L Oxygen Concentrator
Version Model Number33951
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 Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117342736 [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 Date2025-06-11
Device Publish Date2025-06-03

Devices Manufactured by Dynarex Corporation

00810180842273 - WeCare Denture Cleanser, Antibacterial 2025-09-09 Kills Millions of Bacteria, Fight Odor, Removes Stains
00840117321915 - DMECare Solutions Ever-Soft Lumbar Support Cushion,18"2025-09-01 Weight Capacity: 350 LB.
00840117321939 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 20" 2025-09-01 Weight Capacity: 350 LB.
00840117321953 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"2025-09-01 Weight Capacity: 350 LB.
00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO 2025-08-27
00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic 2025-08-11 Sterile-EO
00616784704210 - IV Administration Sets, 10 mL, Non-Toxic 2025-08-11 Sterile-EO
00616784704418 - IV Administration Set, 20 mL, Non-Toxic2025-08-11 Sterile-EO

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.