| Primary Device ID | 06977182812018 |
| NIH Device Record Key | b5a922b4-df70-405a-9479-f72e9d7e9328 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shenzhen Wells Optoelectronics Co.,Ltd. |
| Version Model Number | IR201 |
| Company DUNS | 549645451 |
| Company Name | Shenzhen Wells Optoelectronics Co.,Ltd. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | false |
| OTC Over-The-Counter | false |