AUDIBEL ABL P7N
GUDID 00842318167323
STARKEY LABORATORIES, INC.
In-the-ear air-conduction hearing aid| Primary Device ID | 00842318167323 |
| NIH Device Record Key | 9b177403-59ba-46e7-8772-b938b039f71e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AUDIBEL |
| Version Model Number | AUDIBEL DAVINCI 1600 ITE |
| Catalog Number | ABL P7N |
| 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 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 |
| 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 | 00842318167323 [Primary] |
FDA Product Code
| OSM | Hearing aid, air conduction with wireless technology |
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 | 2018-09-27 |
| Device Publish Date | 2018-08-27 |
On-Brand Devices [AUDIBEL]
| 00842318168290 | AUDIBEL DAVINCI 1000 IIC |
| 00842318168283 | AUDIBEL DAVINCI 1200 IIC |
| 00842318168276 | AUDIBEL DAVINCI 1600 IIC |
| 00842318168269 | AUDIBEL DAVINCI 2000 IIC |
| 00842318168252 | AUDIBEL DAVINCI 2400 IIC |
| 00842318168047 | AUDIBEL DAVINCI I1000 IIC |
| 00842318168030 | AUDIBEL DAVINCI I1200 IIC |
| 00842318168023 | AUDIBEL DAVINCI I1600 IIC |
| 00842318168016 | AUDIBEL DAVINCI I2000 IIC |
| 00842318168009 | AUDIBEL DAVINCI I2400 IIC |
| 00842318167347 | AUDIBEL DAVINCI 1000 ITE |
| 00842318167330 | AUDIBEL DAVINCI 1200 ITE |
| 00842318167323 | AUDIBEL DAVINCI 1600 ITE |
| 00842318167316 | AUDIBEL DAVINCI 2000 ITE |
| 00842318167309 | AUDIBEL DAVINCI 2400 ITE |
| 00842318167293 | AUDIBEL DAVINCI 1000 HALF SHELL |
| 00842318167286 | AUDIBEL DAVINCI 1200 HALF SHELL |
| 00842318167279 | AUDIBEL DAVINCI 1600 HALF SHELL |
| 00842318167262 | AUDIBEL DAVINCI 2000 HALF SHELL |
| 00842318167255 | AUDIBEL DAVINCI 2400 HALF SHELL |
| 00842318167248 | AUDIBEL DAVINCI 1000 ITC |
| 00842318167231 | AUDIBEL DAVINCI 1200 ITC |
| 00842318167224 | AUDIBEL DAVINCI 1600 ITC |
| 00842318167217 | AUDIBEL DAVINCI 2000 ITC |
| 00842318167200 | AUDIBEL DAVINCI 2400 ITC |
| 00842318167194 | AUDIBEL DAVINCI 1000 CIC |
| 00842318167187 | AUDIBEL DAVINCI 1200 CIC |
| 00842318167170 | AUDIBEL DAVINCI 1600 CIC |
| 00842318167163 | AUDIBEL DAVINCI 2000 CIC |
| 00842318167156 | AUDIBEL DAVINCI 2400 CIC |
| 00842318166340 | AUDIBEL DAVINCI I1000 ITE |
| 00842318166333 | AUDIBEL DAVINCI I1200 ITE |
| 00842318166326 | AUDIBEL DAVINCI I1600 ITE |
| 00842318166319 | AUDIBEL DAVINCI I2000 ITE |
| 00842318166302 | AUDIBEL DAVINCI I2400 ITE |
| 00842318166296 | AUDIBEL DAVINCI I1000 HALF SHELL |
| 00842318166289 | AUDIBEL DAVINCI I1200 HALF SHELL |
| 00842318166272 | AUDIBEL DAVINCI I1600 HALF SHELL |
| 00842318166265 | AUDIBEL DAVINCI I2000 HALF SHELL |
| 00842318166258 | AUDIBEL DAVINCI I2400 HALF SHELL |
| 00842318166241 | AUDIBEL DAVINCI I1000 ITC |
| 00842318166234 | AUDIBEL DAVINCI I1200 ITC |
| 00842318166227 | AUDIBEL DAVINCI I1600 ITC |
| 00842318166210 | AUDIBEL DAVINCI I2000 ITC |
| 00842318166203 | AUDIBEL DAVINCI I2400 ITC |
| 00842318166197 | AUDIBEL DAVINCI I1000 CIC |
| 00842318166180 | AUDIBEL DAVINCI I1200 CIC |
| 00842318166173 | AUDIBEL DAVINCI I1600 CIC |
| 00842318166166 | AUDIBEL DAVINCI I2000 CIC |
| 00842318166159 | AUDIBEL DAVINCI I2400 CIC |
Trademark Results [AUDIBEL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUDIBEL 90768794 not registered Live/Pending |
Starkey Laboratories, Inc. 2021-06-11 |
 AUDIBEL 87872834 5595781 Live/Registered |
Starkey Laboratories, Inc. 2018-04-11 |
 AUDIBEL 76385936 2672076 Live/Registered |
STARKEY LABORATORIES, INC. 2002-03-21 |
 AUDIBEL 74181598 1707953 Live/Registered |
STARKEY LABORATORIES, INC. 1991-07-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.