| Primary Device ID | 00867460000106 | 
| NIH Device Record Key | dfcc066e-a928-4edb-a6c9-47207ef954f7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Oxus / GCE | 
| Version Model Number | RS-00500 | 
| Company DUNS | 962894098 | 
| Company Name | OXUS AMERICA, INC. | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | false | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | |
| Phone | 248-475-0925 | 
| rlenarcic@oxusamerica.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00867460000106 [Primary] | 
| CAW | Generator, Oxygen, Portable | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2020-03-30 | 
| Device Publish Date | 2015-07-07 | 
| 00867460000144 | Zen-O™ Clarity Portable Oxygen Concentrator | 
| 00867460000137 | Zen-O Lite Portable Oxygen Concentrator | 
| 00867460000106 | Zen-O™ Portable Oxygen Concentrator |