AUDIGY
GUDID 00840388204184
STARKEY LABORATORIES, INC.
Tinnitus masking application software| Primary Device ID | 00840388204184 |
| NIH Device Record Key | e7a90ba6-413b-4bbf-93bd-5eedd23d3c31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUDIGY |
| Version Model Number | AUDIGY AGXS EDGE AI 24 RIC 312 (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 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 |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840388204184 [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 [AUDIGY]
| 00842318168443 | AUDIGY AGXSPI 1000 IIC |
| 00842318168436 | AUDIGY AGXSPI 1200 IIC |
| 00842318168429 | AUDIGY AGXSPI 1600 IIC |
| 00842318168412 | AUDIGY AGXSPI 2000 IIC |
| 00842318168405 | AUDIGY AGXSPI 2400 IIC |
| 00842318168191 | AUDIGY AGXSPI I1000 IIC |
| 00842318168184 | AUDIGY AGXSPI I1200 IIC |
| 00842318168177 | AUDIGY AGXSPI I1600 IIC |
| 00842318168160 | AUDIGY AGXSPI I2000 IIC |
| 00842318168153 | AUDIGY AGXSPI I2400 IIC |
| 00842318167941 | AUDIGY AGXSPI 1000 ITE |
| 00842318167934 | AUDIGY AGXSPI 1200 ITE |
| 00842318167927 | AUDIGY AGXSPI 1600 ITE |
| 00842318167910 | AUDIGY AGXSPI 2000 ITE |
| 00842318167903 | AUDIGY AGXSPI 2400 ITE |
| 00842318167897 | AUDIGY AGXSPI 1000 HALF SHELL |
| 00842318167880 | AUDIGY AGXSPI 1200 HALF SHELL |
| 00842318167873 | AUDIGY AGXSPI 1600 HALF SHELL |
| 00842318167866 | AUDIGY AGXSPI 2000 HALF SHELL |
| 00842318167859 | AUDIGY AGXSPI 2400 HALF SHELL |
| 00842318167842 | AUDIGY AGXSPI 1000 ITC |
| 00842318167835 | AUDIGY AGXSPI 1200 ITC |
| 00842318167828 | AUDIGY AGXSPI 1600 ITC |
| 00842318167811 | AUDIGY AGXSPI 2000 ITC |
| 00842318167804 | AUDIGY AGXSPI 2400 ITC |
| 00842318167798 | AUDIGY AGXSPI 1000 CIC |
| 00842318167781 | AUDIGY AGXSPI 1200 CIC |
| 00842318167774 | AUDIGY AGXSPI 1600 CIC |
| 00842318167767 | AUDIGY AGXSPI 2000 CIC |
| 00842318167750 | AUDIGY AGXSPI 2400 CIC |
| 00842318166944 | AUDIGY AGXSPI I1000 ITE |
| 00842318166937 | AUDIGY AGXSPI I1200 ITE |
| 00842318166920 | AUDIGY AGXSPI I1600 ITE |
| 00842318166913 | AUDIGY AGXSPI I2000 ITE |
| 00842318166906 | AUDIGY AGXSPI I2400 ITE |
| 00842318166890 | AUDIGY AGXSPI I1000 HALF SHELL |
| 00842318166883 | AUDIGY AGXSPI I1200 HALF SHELL |
| 00842318166876 | AUDIGY AGXSPI I1600 HALF SHELL |
| 00842318166869 | AUDIGY AGXSPI I2000 HALF SHELL |
| 00842318166852 | AUDIGY AGXSPI I2400 HALF SHELL |
| 00842318166845 | AUDIGY AGXSPI I1000 ITC |
| 00842318166838 | AUDIGY AGXSPI I1200 ITC |
| 00842318166821 | AUDIGY AGXSPI I1600 ITC |
| 00842318166814 | AUDIGY AGXSPI I2000 ITC |
| 00842318166807 | AUDIGY AGXSPI I2400 ITC |
| 00842318166791 | AUDIGY AGXSPI I1000 CIC |
| 00842318166784 | AUDIGY AGXSPI I1200 CIC |
| 00842318166777 | AUDIGY AGXSPI I1600 CIC |
| 00842318166760 | AUDIGY AGXSPI I2000 CIC |
| 00842318166753 | AUDIGY AGXSPI I2400 CIC |
Trademark Results [AUDIGY]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUDIGY 78401250 3030542 Live/Registered |
RESOUND HOLDINGS, INC. 2004-04-13 |
 AUDIGY 76204714 2737843 Live/Registered |
Creative Technology Ltd. 2001-02-01 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.