| Primary Device ID | 00860005068319 |
| NIH Device Record Key | 629e4b94-a904-40c4-b97e-0dcdc5bbd271 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Audhere Software |
| Version Model Number | 0.X.X |
| Company DUNS | 006702621 |
| Company Name | Edare LLC |
| 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com | |
| Phone | 603-640-2865 |
| info@wahtshearing.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860005068319 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-26 |
| Device Publish Date | 2024-04-18 |
| 00860005068319 - Audhere Software | 2024-04-26 |
| 00860005068319 - Audhere Software | 2024-04-26 |
| 00860005068302 - WAHTS | 2021-02-08 |