| Primary Device ID | 16933257921853 |
| NIH Device Record Key | 279d274f-ac60-4645-a06a-20252f51c869 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | YUWELL Oxygen Concentrator |
| Version Model Number | 8F-5A |
| Company DUNS | 528704000 |
| Company Name | Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | 06933257921856 [Primary] |
| GS1 | 16933257921853 [Package] Contains: 06933257921856 Package: [1 Units] In Commercial Distribution |
| CAW | Generator, Oxygen, Portable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-03-25 |
| Device Publish Date | 2024-01-09 |
| 16933257921853 | This oxygen concentrator is intended for individual use as an oxygen supplement device in the pr |
| 06933257921849 | This oxygen concentrator is intended for individual use as an oxygen supplement device in the pr |