| Primary Device ID | 06973375880154 |
| NIH Device Record Key | 8f6c6830-c788-474a-938b-26e6ce2093a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACOSOUND |
| Version Model Number | Leya-W-BTE-P |
| Company DUNS | 542986440 |
| Company Name | Hangzhou AcoSound 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973375880154 [Primary] |
| ESD | Hearing Aid, Air Conduction |
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-27 |
| Device Publish Date | 2022-04-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACOSOUND 87736474 not registered Live/Pending |
Hangzhou Acosound Technology Co.,Ltd. 2017-12-28 |