otoTune™ app
GUDID 00850016231383
APP, Bluetooth, otoTune™, iOS
Soundwave Hearing, LLC
Hearing aid/implant system remote control| Primary Device ID | 00850016231383 |
| NIH Device Record Key | 832b6641-36e6-4061-8eaa-d5d28cd7f99e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | otoTune™ app |
| Version Model Number | 990019-SWH |
| Company DUNS | 050441605 |
| Company Name | Soundwave Hearing, 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850016231383 [Primary] |
FDA Product Code
| OSM | Hearing Aid, Air Conduction With Wireless Technology |
| QUG | Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| QUH | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
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 | 2021-11-09 |
| Device Publish Date | 2021-11-01 |
On-Brand Devices [otoTune™ app]
| 00850016231390 | APP, Bluetooth, otoTune™, Android |
| 00850016231383 | APP, Bluetooth, otoTune™, iOS |
Trademark Results [otoTune]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OTOTUNE 87856399 not registered Live/Pending |
SOUNDWAVE HEARING, LLC 2018-03-29 |
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