| Primary Device ID | 08592346004337 |
| NIH Device Record Key | 4bdc9c8a-8418-420f-9691-d997526b9439 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GCE |
| Version Model Number | RS-00500 |
| Company DUNS | 296797616 |
| Company Name | GAS CONTROL EQUIPMENT LIMITED |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08592346004337 [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 | 5 |
| Public Version Date | 2020-04-20 |
| Device Publish Date | 2018-01-01 |
| 08592346679832 | Zen-O™ Clarity Portable Oxygen Concentrator |
| 08592346658110 | Zen-O Lite Portable Oxygen Concentrator |
| 08592346004337 | Zen-O™ Portable Oxygen Concentrator |
| 05060456420000 | Zen-O Lite Clarity Portable Oxygen Concentrator |
| 08592346904156 | Zen-O™ Portable Oxygen Concentrator |
| 08592346805477 | ZenO Lite Portable Oxygen Concentrator |