| Primary Device ID | 00850010429274 |
| NIH Device Record Key | c2887a5d-29bd-43ba-9fd4-f8a37efc52ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eargo RX |
| Version Model Number | 99-0178-001 |
| Company DUNS | 079865289 |
| Company Name | Eargo, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | 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 |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com | |
| Phone | 1 (855) 690-9360 |
| info@eargo.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850010429274 [Primary] |
| QDD | Self-Fitting Air-Conduction Hearing Aid, 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 | 2024-06-25 |
| Device Publish Date | 2024-06-17 |
| 00850010429274 | Eargo SE-Rx New System |
| 00850010429205 | Eargo 7-Rx New System |