AUDIOSYNC 64335-J

GUDID 00842318116352

STARKEY LABORATORIES, INC.

Tinnitus masking application software

• Primary Device ID: 00842318116352
• NIH Device Record Key: cd6c647d-8f5e-4710-af47-f0b61ae06c92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AUDIOSYNC
• Version Model Number: A4 CROS RIC 312t
• Catalog Number: 64335-J
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842318116352 [Primary]

FDA Product Code

• KLW: Masker, tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-01-10

On-Brand Devices [AUDIOSYNC]

• 00842318160003: AUDIOSYNC VIA 1000 RIC 312
• 00842318154194: AUDIOSYNC VIA 1200 RIC 312
• 00842318154125: AUDIOSYNC VIA 1200 RIC 312
• 00842318153296: AUDIOSYNC VIA 1600 RIC 312
• 00842318152800: AUDIOSYNC VIA 2000 RIC 312
• 00842318152244: AUDIOSYNC VIA 2400 RIC 312
• 00842318151612: AUDIOSYNC VIA AI 1000 RIC 312
• 00842318150844: AUDIOSYNC VIA AI 1200 RIC 312
• 00842318150776: AUDIOSYNC VIA AI 1200 RIC 312
• 00842318150288: AUDIOSYNC VIA AI 1600 RIC 312
• 00842318148476: AUDIOSYNC VIA AI 2000 RIC 312
• 00842318148407: AUDIOSYNC VIA AI 2400 RIC 312
• 00842318148315: AUDIOSYNC VIA 2400 RIC 312
• 00842318148261: AUDIOSYNC VIA AI 2400 RIC 312
• 00842318148216: AUDIOSYNC VIA 1000 BTE 13
• 00842318148131: AUDIOSYNC VIA 1200 BTE 13
• 00842318148124: AUDIOSYNC VIA 1200 BTE 13
• 00842318148049: AUDIOSYNC VIA 1600 BTE 13
• 00842318147974: AUDIOSYNC VIA 2000 BTE 13
• 00842318147899: AUDIOSYNC VIA 2400 BTE 13
• 00842318147820: AUDIOSYNC VIA AI 1000 BTE 13
• 00842318147752: AUDIOSYNC VIA AI 1200 BTE 13
• 00842318147745: AUDIOSYNC VIA AI 1200 BTE 13
• 00842318147677: AUDIOSYNC VIA AI 1600 BTE 13
• 00842318147608: AUDIOSYNC VIA AI 2000 BTE 13
• 00842318147530: AUDIOSYNC VIA AI 2400 BTE 13
• 00842318147455: AUDIOSYNC VIA 2400 BTE 13
• 00842318147400: AUDIOSYNC VIA AI 2400 BTE 13
• 00842318117168: START 1000 RIC 312t
• 00842318117076: START 1200 RIC 312t
• 00842318117069: START 1200 RIC 312t
• 00842318116994: A4 SILVER RIC 312t
• 00842318116925: A4 GOLD RIC 312t
• 00842318116857: A4 PLATINUM RIC 312t
• 00842318116789: START 1000I WRLS RIC 312
• 00842318116680: START 1200I WRLS RIC 312
• 00842318116673: START 1200I WRLS RIC 312
• 00842318116598: A4I SILVER WRLS RIC 312
• 00842318116512: A4I GOLD WRLS RIC 312
• 00842318116437: A4I PLATINUM WRLS RIC 312
• 00842318116352: A4 CROS RIC 312t
• 00842318116284: START 1000 WRLS RIC 312t
• 00842318116192: START 1200 WRLS RIC 312t
• 00842318116185: START 1200 WRLS RIC 312t
• 00842318116116: A4 SILVER WRLS RIC 312t
• 00842318116048: A4 GOLD WRLS RIC 312t
• 00842318115973: A4 PLATINUM WRLS RIC 312t
• 00842318114822: DEBUT 245W CIC
• 00842318114754: DEBUT 165W CIC
• 00842318114655: DEBUT 95W CIC