AUDIGY 63196-A

GUDID 00842318177759

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 ID00842318177759
NIH Device Record Key0d9cbe96-5e07-4c8b-b666-dbb520bcac7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUDIGY
Version Model NumberAUDIGY AGXSLIV EDGE AI 2400 BTE R
Catalog Number63196-A
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 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
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100842318177759 [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 [AUDIGY]

00842318168443AUDIGY AGXSPI 1000 IIC
00842318168436AUDIGY AGXSPI 1200 IIC
00842318168429AUDIGY AGXSPI 1600 IIC
00842318168412AUDIGY AGXSPI 2000 IIC
00842318168405AUDIGY AGXSPI 2400 IIC
00842318168191AUDIGY AGXSPI I1000 IIC
00842318168184AUDIGY AGXSPI I1200 IIC
00842318168177AUDIGY AGXSPI I1600 IIC
00842318168160AUDIGY AGXSPI I2000 IIC
00842318168153AUDIGY AGXSPI I2400 IIC
00842318167941AUDIGY AGXSPI 1000 ITE
00842318167934AUDIGY AGXSPI 1200 ITE
00842318167927AUDIGY AGXSPI 1600 ITE
00842318167910AUDIGY AGXSPI 2000 ITE
00842318167903AUDIGY AGXSPI 2400 ITE
00842318167897AUDIGY AGXSPI 1000 HALF SHELL
00842318167880AUDIGY AGXSPI 1200 HALF SHELL
00842318167873AUDIGY AGXSPI 1600 HALF SHELL
00842318167866AUDIGY AGXSPI 2000 HALF SHELL
00842318167859AUDIGY AGXSPI 2400 HALF SHELL
00842318167842AUDIGY AGXSPI 1000 ITC
00842318167835AUDIGY AGXSPI 1200 ITC
00842318167828AUDIGY AGXSPI 1600 ITC
00842318167811AUDIGY AGXSPI 2000 ITC
00842318167804AUDIGY AGXSPI 2400 ITC
00842318167798AUDIGY AGXSPI 1000 CIC
00842318167781AUDIGY AGXSPI 1200 CIC
00842318167774AUDIGY AGXSPI 1600 CIC
00842318167767AUDIGY AGXSPI 2000 CIC
00842318167750AUDIGY AGXSPI 2400 CIC
00842318166944AUDIGY AGXSPI I1000 ITE
00842318166937AUDIGY AGXSPI I1200 ITE
00842318166920AUDIGY AGXSPI I1600 ITE
00842318166913AUDIGY AGXSPI I2000 ITE
00842318166906AUDIGY AGXSPI I2400 ITE
00842318166890AUDIGY AGXSPI I1000 HALF SHELL
00842318166883AUDIGY AGXSPI I1200 HALF SHELL
00842318166876AUDIGY AGXSPI I1600 HALF SHELL
00842318166869AUDIGY AGXSPI I2000 HALF SHELL
00842318166852AUDIGY AGXSPI I2400 HALF SHELL
00842318166845AUDIGY AGXSPI I1000 ITC
00842318166838AUDIGY AGXSPI I1200 ITC
00842318166821AUDIGY AGXSPI I1600 ITC
00842318166814AUDIGY AGXSPI I2000 ITC
00842318166807AUDIGY AGXSPI I2400 ITC
00842318166791AUDIGY AGXSPI I1000 CIC
00842318166784AUDIGY AGXSPI I1200 CIC
00842318166777AUDIGY AGXSPI I1600 CIC
00842318166760AUDIGY AGXSPI I2000 CIC
00842318166753AUDIGY AGXSPI I2400 CIC

Trademark Results [AUDIGY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUDIGY
AUDIGY
78401250 3030542 Live/Registered
RESOUND HOLDINGS, INC.
2004-04-13
AUDIGY
AUDIGY
76204714 2737843 Live/Registered
Creative Technology Ltd.
2001-02-01

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