| Primary Device ID | 00867460000137 |
| NIH Device Record Key | 3c625837-94c3-4697-814f-2e446ad7d890 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxus / GCE |
| Version Model Number | RS-00600 |
| 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 | 00867460000137 [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 | 2017-01-01 |
| 00867460000144 | Zen-O™ Clarity Portable Oxygen Concentrator |
| 00867460000137 | Zen-O Lite Portable Oxygen Concentrator |
| 00867460000106 | Zen-O™ Portable Oxygen Concentrator |