NUEAR
GUDID 00840388203507
STARKEY LABORATORIES, INC.
Tinnitus masking application software| Primary Device ID | 00840388203507 |
| NIH Device Record Key | 260203a0-90b3-4837-aa64-5dbd79f6ad01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NUEAR |
| Version Model Number | NUEAR EDGE AI 24 MRIC R (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 | 00840388203507 [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 [NUEAR]
| 00842318168344 | NUEAR CANVAS 1000 IIC |
| 00842318168337 | NUEAR CANVAS 1200 IIC |
| 00842318168320 | NUEAR CANVAS 1600 IIC |
| 00842318168313 | NUEAR CANVAS 2000 IIC |
| 00842318168306 | NUEAR CANVAS 2400 IIC |
| 00842318168092 | NUEAR CANVAS I1000 IIC |
| 00842318168085 | NUEAR CANVAS I1200 IIC |
| 00842318168078 | NUEAR CANVAS I1600 IIC |
| 00842318168061 | NUEAR CANVAS I2000 IIC |
| 00842318168054 | NUEAR CANVAS I2400 IIC |
| 00842318167545 | NUEAR CANVAS 1000 ITE |
| 00842318167538 | NUEAR CANVAS 1200 ITE |
| 00842318167521 | NUEAR CANVAS 1600 ITE |
| 00842318167514 | NUEAR CANVAS 2000 ITE |
| 00842318167507 | NUEAR CANVAS 2400 ITE |
| 00842318167491 | NUEAR CANVAS 1000 HALF SHELL |
| 00842318167484 | NUEAR CANVAS 1200 HALF SHELL |
| 00842318167477 | NUEAR CANVAS 1600 HALF SHELL |
| 00842318167460 | NUEAR CANVAS 2000 HALF SHELL |
| 00842318167453 | NUEAR CANVAS 2400 HALF SHELL |
| 00842318167446 | NUEAR CANVAS 1000 ITC |
| 00842318167439 | NUEAR CANVAS 1200 ITC |
| 00842318167422 | NUEAR CANVAS 1600 ITC |
| 00842318167415 | NUEAR CANVAS 2000 ITC |
| 00842318167408 | NUEAR CANVAS 2400 ITC |
| 00842318167392 | NUEAR CANVAS 1000 CIC |
| 00842318167385 | NUEAR CANVAS 1200 CIC |
| 00842318167378 | NUEAR CANVAS 1600 CIC |
| 00842318167361 | NUEAR CANVAS 2000 CIC |
| 00842318167354 | NUEAR CANVAS 2400 CIC |
| 00842318166548 | NUEAR CANVAS I1000 ITE |
| 00842318166531 | NUEAR CANVAS I1200 ITE |
| 00842318166524 | NUEAR CANVAS I1600 ITE |
| 00842318166517 | NUEAR CANVAS I2000 ITE |
| 00842318166500 | NUEAR CANVAS I2400 ITE |
| 00842318166494 | NUEAR CANVAS I1000 HALF SHELL |
| 00842318166487 | NUEAR CANVAS I1200 HALF SHELL |
| 00842318166470 | NUEAR CANVAS I1600 HALF SHELL |
| 00842318166463 | NUEAR CANVAS I2000 HALF SHELL |
| 00842318166456 | NUEAR CANVAS I2400 HALF SHELL |
| 00842318166449 | NUEAR CANVAS I1000 ITC |
| 00842318166432 | NUEAR CANVAS I1200 ITC |
| 00842318166425 | NUEAR CANVAS I1600 ITC |
| 00842318166418 | NUEAR CANVAS I2000 ITC |
| 00842318166401 | NUEAR CANVAS I2400 ITC |
| 00842318166395 | NUEAR CANVAS I1000 CIC |
| 00842318166388 | NUEAR CANVAS I1200 CIC |
| 00842318166371 | NUEAR CANVAS I1600 CIC |
| 00842318166364 | NUEAR CANVAS I2000 CIC |
| 00842318166357 | NUEAR CANVAS I2400 CIC |
Trademark Results [NUEAR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NUEAR 87859589 5595765 Live/Registered |
Starkey Laboratories, Inc. 2018-04-02 |
 NUEAR 87057864 5119293 Live/Registered |
Starkey Laboratories, Inc. 2016-06-02 |
 NUEAR 86542607 not registered Dead/Abandoned |
Starkey Laboratories, Inc. 2015-02-23 |
 NUEAR 73485082 1328355 Live/Registered |
B & B Marketing & Development, Inc. 1984-06-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.