Oxus / GCE

GUDID 00867460000144

Zen-O™ Clarity Portable Oxygen Concentrator

OXUS AMERICA, INC.

Portable oxygen concentrator
Primary Device ID00867460000144
NIH Device Record Key238f2082-d99a-4612-91b7-60561648598e
Commercial Distribution StatusIn Commercial Distribution
Brand NameOxus / GCE
Version Model NumberRS-00502C
Company DUNS962894098
Company NameOXUS AMERICA, INC.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone248-475-0925
Emailrlenarcic@oxusamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100867460000144 [Primary]

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 Date2018-04-02
Device Publish Date2018-03-01

On-Brand Devices [Oxus / GCE]

00867460000144Zen-O™ Clarity Portable Oxygen Concentrator
00867460000137Zen-O Lite Portable Oxygen Concentrator
00867460000106Zen-O™ Portable Oxygen Concentrator

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