Lexie Hearing In-Store
GUDID 00850022464577
Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids
HEARX GROUP (PTY) LTD
Air-conduction hearing aid, receiver-in-canal| Primary Device ID | 00850022464577 |
| NIH Device Record Key | 8cbb8d69-50ff-408e-b6a8-fcdb7ebdc7d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lexie Hearing |
| Version Model Number | Lexie B1 Self-fitting OTC Hearing Aids Powered by |
| Catalog Number | In-Store |
| Company DUNS | 539177681 |
| Company Name | HEARX GROUP (PTY) LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com | |
| Phone | (800) 499-1336 |
| support@lexiehearing.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Handling Environment Temperature: between 0 and 45 degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850022464577 [Primary] |
| GS1 | 10850022464574 [Package] Package: Case [6 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211008
FDA Product Code
| QDD | Self-Fitting Air-Conduction Hearing Aid |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-13 |
| Device Publish Date | 2022-10-05 |
On-Brand Devices [Lexie Hearing]
| 00850022464263 | iOS Hearing Aid Programming App |
| 00850022464256 | Android Hearing Aid Programming App |
| 10860003469801 | Lexie Lumen self-fitting Beige hearing aid - Duo |
| 10850022464000 | Lexie Lumen self-fitting Silver hearing aid - Duo |
| 10850022464642 | Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid |
| 00850022464577 | Lexie B1 Hearing Aids, powered by Bose. Self-fit, app-controlled hearing aids |
| 00850022464942 | Lexie B2 Self-fitting OTC Hearing Aids, Powered by Bose (BTE, Grey) |
| 00850022464157 | Lexie Lumen OTC Hearing Aids - Beige Online |
| 00860003469880 | Lexie Lumen Duo Metalic Black - Online |
| 00860003469866 | Lexie Lumen Duo Bronze - Online |
| 00860003469842 | Lexie Lumen Duo Light Gray - Online |
| 00850022464171 | Lexie Lumen Duo Silver - Online |
| 00850022464065 | Lexie Lumen OTC Hearing Aids - Gray Online |
| 00810153660163 | Refurbished Lexie B2 Plus Powered by Bose |
| 00810153660156 | Refurbished Lexie B2 Powered by Bose |
| 00810153660149 | Refurbished Lexie B1 Powered by Bose |
| 00810153660811 | Lexie B2 Powered by Bose (AARP) |
Trademark Results [Lexie Hearing]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LEXIE HEARING 98220205 not registered Live/Pending |
hearX USA Inc. 2023-10-12 |
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