AUDIOSYNC 63195-J, 63203-J

GUDID 00842318178039

STARKEY LABORATORIES, INC.

Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software Tinnitus masking application software
Primary Device ID00842318178039
NIH Device Record Key2a6283ee-c370-4580-9966-16eb19ca7ec8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUDIOSYNC
Version Model NumberAUDIOSYNC VIA EDGE AI 2400 BTE 13
Catalog Number63195-J, 63203-J
Company DUNS055461479
Company NameSTARKEY LABORATORIES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100842318178039 [Primary]

FDA Product Code

KLWMasker, tinnitus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-19
Device Publish Date2020-03-11

On-Brand Devices [AUDIOSYNC]

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

Trademark Results [AUDIOSYNC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUDIOSYNC
AUDIOSYNC
88031966 not registered Live/Pending
Stenograph L.L.C.
2018-07-10
AUDIOSYNC
AUDIOSYNC
85447206 4154102 Live/Registered
ACCUQUEST HEARING CENTER, INC.
2011-10-13

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