AUDIBEL ABL P9N

GUDID 00842318167316

STARKEY LABORATORIES, INC.

In-the-ear air-conduction hearing aid

• Primary Device ID: 00842318167316
• NIH Device Record Key: 378b7fcb-16b8-4f87-a1fd-acf6bde0bbc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUDIBEL
• Version Model Number: AUDIBEL DAVINCI 2000 ITE
• Catalog Number: ABL P9N
• 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 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	00842318167316 [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: 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