| Primary Device ID | 00869694000105 |
| NIH Device Record Key | c4f67b8f-cf2d-42fb-b648-0e92dcbdba43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oxlife Independence POC |
| Version Model Number | 301-0001V |
| Company DUNS | 034756852 |
| Company Name | O2 CONCEPTS, LLC |
| 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 | 877-867-4008 |
| info@o2-concepts.com |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00869694000105 [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 | 2019-02-18 |
| Device Publish Date | 2017-07-13 |
| 00869694000112 | The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration |
| 00869694000105 | The O2 Concepts Oxlife Independence is indicated on a prescription basis for the administration |