AUDIOSYNC
GUDID 00840388203651
STARKEY LABORATORIES, INC.
Air-conduction hearing aid, receiver-in-canal| Primary Device ID | 00840388203651 |
| NIH Device Record Key | fcb09dfe-534e-4539-9412-f7cccb402380 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUDIOSYNC |
| Version Model Number | AUDIOSYNC EDGE AI 24 MRIC R (TIER DEMO) |
| Company DUNS | 055461479 |
| Company Name | STARKEY LABORATORIES, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840388203651 [Primary] |
FDA Product Code
| KLW | Masker, tinnitus |
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 | 2024-12-09 |
| Device Publish Date | 2024-11-29 |
On-Brand Devices [AUDIOSYNC]
| 00842318160003 | AUDIOSYNC VIA 1000 RIC 312 |
| 00842318154194 | AUDIOSYNC VIA 1200 RIC 312 |
| 00842318154125 | AUDIOSYNC VIA 1200 RIC 312 |
| 00842318153296 | AUDIOSYNC VIA 1600 RIC 312 |
| 00842318152800 | AUDIOSYNC VIA 2000 RIC 312 |
| 00842318152244 | AUDIOSYNC VIA 2400 RIC 312 |
| 00842318151612 | AUDIOSYNC VIA AI 1000 RIC 312 |
| 00842318150844 | AUDIOSYNC VIA AI 1200 RIC 312 |
| 00842318150776 | AUDIOSYNC VIA AI 1200 RIC 312 |
| 00842318150288 | AUDIOSYNC VIA AI 1600 RIC 312 |
| 00842318148476 | AUDIOSYNC VIA AI 2000 RIC 312 |
| 00842318148407 | AUDIOSYNC VIA AI 2400 RIC 312 |
| 00842318148315 | AUDIOSYNC VIA 2400 RIC 312 |
| 00842318148261 | AUDIOSYNC VIA AI 2400 RIC 312 |
| 00842318148216 | AUDIOSYNC VIA 1000 BTE 13 |
| 00842318148131 | AUDIOSYNC VIA 1200 BTE 13 |
| 00842318148124 | AUDIOSYNC VIA 1200 BTE 13 |
| 00842318148049 | AUDIOSYNC VIA 1600 BTE 13 |
| 00842318147974 | AUDIOSYNC VIA 2000 BTE 13 |
| 00842318147899 | AUDIOSYNC VIA 2400 BTE 13 |
| 00842318147820 | AUDIOSYNC VIA AI 1000 BTE 13 |
| 00842318147752 | AUDIOSYNC VIA AI 1200 BTE 13 |
| 00842318147745 | AUDIOSYNC VIA AI 1200 BTE 13 |
| 00842318147677 | AUDIOSYNC VIA AI 1600 BTE 13 |
| 00842318147608 | AUDIOSYNC VIA AI 2000 BTE 13 |
| 00842318147530 | AUDIOSYNC VIA AI 2400 BTE 13 |
| 00842318147455 | AUDIOSYNC VIA 2400 BTE 13 |
| 00842318147400 | AUDIOSYNC VIA AI 2400 BTE 13 |
| 00842318117168 | START 1000 RIC 312t |
| 00842318117076 | START 1200 RIC 312t |
| 00842318117069 | START 1200 RIC 312t |
| 00842318116994 | A4 SILVER RIC 312t |
| 00842318116925 | A4 GOLD RIC 312t |
| 00842318116857 | A4 PLATINUM RIC 312t |
| 00842318116789 | START 1000I WRLS RIC 312 |
| 00842318116680 | START 1200I WRLS RIC 312 |
| 00842318116673 | START 1200I WRLS RIC 312 |
| 00842318116598 | A4I SILVER WRLS RIC 312 |
| 00842318116512 | A4I GOLD WRLS RIC 312 |
| 00842318116437 | A4I PLATINUM WRLS RIC 312 |
| 00842318116352 | A4 CROS RIC 312t |
| 00842318116284 | START 1000 WRLS RIC 312t |
| 00842318116192 | START 1200 WRLS RIC 312t |
| 00842318116185 | START 1200 WRLS RIC 312t |
| 00842318116116 | A4 SILVER WRLS RIC 312t |
| 00842318116048 | A4 GOLD WRLS RIC 312t |
| 00842318115973 | A4 PLATINUM WRLS RIC 312t |
| 00842318114822 | DEBUT 245W CIC |
| 00842318114754 | DEBUT 165W CIC |
| 00842318114655 | DEBUT 95W CIC |
Trademark Results [AUDIOSYNC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUDIOSYNC 88031966 not registered Live/Pending |
Stenograph L.L.C. 2018-07-10 |
 AUDIOSYNC 85447206 4154102 Live/Registered |
ACCUQUEST HEARING CENTER, INC. 2011-10-13 |
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