| Primary Device ID | 00850010429168 | 
| NIH Device Record Key | 725949fb-340c-428d-bf98-54727035de28 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EARGO | 
| Version Model Number | 99-0110-001 | 
| Catalog Number | 99-0110-001 | 
| Company DUNS | 079865289 | 
| Company Name | Eargo, Inc. | 
| Device Count | 6 | 
| DM Exempt | true | 
| 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 | false | 
| 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 | 
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@eargo.com | |
| Phone | +1(408)355-8045 | 
| ronald.gonterman@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 | |
| 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 | |
| Phone | 1 (855) 690-9360 | 
| info@eargo.com | |
| Phone | 1 (855) 690-9360 | 
| info@eargo.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850010429168 [Primary] | 
| GS1 | 10850010429165 [Unit of Use] | 
| ESD | Hearing aid, air conduction | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-01-27 | 
| Device Publish Date | 2020-01-17 | 
| 00850010429120 | EARGO Replacement Flexi Palm, Size Large | 
| 00850010429113 | EARGO Replacement Flexi Palm, Size Regular | 
| 00850010429106 | EARGO Replacement Flexi Fiber, Size Large | 
| 00850010429090 | EARGO Replacement Flexi Dome, Size Large | 
| 00850010429083 | EARGO Replacement Flexi Fiber, Size Regular | 
| 00850010429069 | EARGO Replacement Flexi Dome, Size Regular | 
| 00850010429052 | EARGO NEO, Replacement Hearing Device, Left | 
| 00850010429045 | EARGO NEO, Replacement Hearing Device, Right | 
| 00850010429038 | EARGO NEO Charger Replacement | 
| 00850010429021 | EARGO NEO System | 
| 00850010429175 | EARGO NEO HiFi, Accessory Kit, Tetra Flexi Palm, Size Large | 
| 00850010429168 | EARGO NEO HiFi, Accessory Kit, Tetra Flexi Palm, Size Regular | 
| 00850010429151 | EARGO NEO HiFi, Replacement Hearing Device, Left | 
| 00850010429144 | EARGO NEO HiFi, Replacement Hearing Device, Right | 
| 00850010429137 | EARGO NEO HiFi System | 
| 00850010429076 | EARGO NEO HiFi Charger Replacement | 
| 10850010429189 | EARGO NEO ACCESSORY KIT, FLEXI PALM, SIZE SMALL | 
| 00850010429441 | Eargo 5, 6 & 7 Charger, Power Cord & Adaptor | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EARGO  90549643  not registered Live/Pending | Eargo, Inc. 2021-02-26 | 
|  EARGO  86229148  4661088 Live/Registered | EARGO, INC. 2014-03-22 | 
|  EARGO  76328749  2738416 Dead/Cancelled | Bosch, John 2001-10-24 |