AFFLELOU
GUDID 00840388203019
STARKEY LABORATORIES, INC.
Tinnitus masking application software| Primary Device ID | 00840388203019 |
| NIH Device Record Key | fe3ca34a-51ab-4bb5-9cf6-c85e6c5224cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AFFLELOU |
| Version Model Number | AFFLELOU INCOGNITO SIGNATURE 12 CIC NW |
| 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 |
| 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 | 00840388203019 [Primary] |
FDA Product Code
| ESD | Hearing Aid, Air-Conduction, Prescription |
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 | 2025-07-03 |
| Device Publish Date | 2025-06-25 |
On-Brand Devices [AFFLELOU]
| 00840388209448 | Incognito GS 12 RIC 312 |
| 00840388203019 | AFFLELOU INCOGNITO SIGNATURE 12 CIC NW |
| 00840388203002 | AFFLELOU INCOGNITO SIGNATURE 16 CIC NW |
| 00840388202999 | AFFLELOU INCOGNITO SIGNATURE 24 CIC NW |
| 00840388202975 | AFFLELOU INCOGNITO SIGNATURE 12 CIC R NW |
| 00840388202968 | AFFLELOU INCOGNITO SIGNATURE 16 CIC R NW |
| 00840388202951 | AFFLELOU INCOGNITO SIGNATURE 24 CIC R NW |
| 00840388211588 | Incognito OM AI CROS RIC RT |
| 00840388211090 | Incognito OM AI 16 CIC |
| 00840388211083 | Incognito OM AI 24 CIC |
| 00840388210529 | Incognito OM AI 16 mRIC |
| 00840388210512 | Incognito OM AI 24 mRIC |
| 00840388207383 | Incognito Edge AI 24 RIC RT (TIER DEMO) |
| 00840388207154 | INCOGNITO OM AI 16 RIC RT |
| 00840388206881 | Incognito OM AI 24 RIC RT |
Trademark Results [AFFLELOU]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AFFLELOU 86719471 4887105 Live/Registered |
Alain Afflelou Franchiseur 2015-08-10 |
 AFFLELOU 79160311 not registered Dead/Abandoned |
ALAIN AFFLELOU FRANCHISEUR 2014-10-29 |
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