| Primary Device ID | 06945936702588 |
| NIH Device Record Key | 38c22e0b-daae-4970-a7c1-5baf9cf1bec6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMH |
| Version Model Number | Flute R ITC |
| Company DUNS | 528181200 |
| Company Name | Xiamen New Sound Technology 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 |