AUDIBEL 63198-2

GUDID 00842318177483

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 ID00842318177483
NIH Device Record Keye3321aad-c286-4b47-b90b-b30c2864c562
Commercial Distribution StatusIn Commercial Distribution
Brand NameAUDIBEL
Version Model NumberAUDIBEL VIA EDGE AI CROSBICROS BTE 13
Catalog Number63198-2
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
GS100842318177483 [Primary]

FDA Product Code

OSMHearing aid, air conduction with wireless technology

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 [AUDIBEL]

00842318168290AUDIBEL DAVINCI 1000 IIC
00842318168283AUDIBEL DAVINCI 1200 IIC
00842318168276AUDIBEL DAVINCI 1600 IIC
00842318168269AUDIBEL DAVINCI 2000 IIC
00842318168252AUDIBEL DAVINCI 2400 IIC
00842318168047AUDIBEL DAVINCI I1000 IIC
00842318168030AUDIBEL DAVINCI I1200 IIC
00842318168023AUDIBEL DAVINCI I1600 IIC
00842318168016AUDIBEL DAVINCI I2000 IIC
00842318168009AUDIBEL DAVINCI I2400 IIC
00842318167347AUDIBEL DAVINCI 1000 ITE
00842318167330AUDIBEL DAVINCI 1200 ITE
00842318167323AUDIBEL DAVINCI 1600 ITE
00842318167316AUDIBEL DAVINCI 2000 ITE
00842318167309AUDIBEL DAVINCI 2400 ITE
00842318167293AUDIBEL DAVINCI 1000 HALF SHELL
00842318167286AUDIBEL DAVINCI 1200 HALF SHELL
00842318167279AUDIBEL DAVINCI 1600 HALF SHELL
00842318167262AUDIBEL DAVINCI 2000 HALF SHELL
00842318167255AUDIBEL DAVINCI 2400 HALF SHELL
00842318167248AUDIBEL DAVINCI 1000 ITC
00842318167231AUDIBEL DAVINCI 1200 ITC
00842318167224AUDIBEL DAVINCI 1600 ITC
00842318167217AUDIBEL DAVINCI 2000 ITC
00842318167200AUDIBEL DAVINCI 2400 ITC
00842318167194AUDIBEL DAVINCI 1000 CIC
00842318167187AUDIBEL DAVINCI 1200 CIC
00842318167170AUDIBEL DAVINCI 1600 CIC
00842318167163AUDIBEL DAVINCI 2000 CIC
00842318167156AUDIBEL DAVINCI 2400 CIC
00842318166340AUDIBEL DAVINCI I1000 ITE
00842318166333AUDIBEL DAVINCI I1200 ITE
00842318166326AUDIBEL DAVINCI I1600 ITE
00842318166319AUDIBEL DAVINCI I2000 ITE
00842318166302AUDIBEL DAVINCI I2400 ITE
00842318166296AUDIBEL DAVINCI I1000 HALF SHELL
00842318166289AUDIBEL DAVINCI I1200 HALF SHELL
00842318166272AUDIBEL DAVINCI I1600 HALF SHELL
00842318166265AUDIBEL DAVINCI I2000 HALF SHELL
00842318166258AUDIBEL DAVINCI I2400 HALF SHELL
00842318166241AUDIBEL DAVINCI I1000 ITC
00842318166234AUDIBEL DAVINCI I1200 ITC
00842318166227AUDIBEL DAVINCI I1600 ITC
00842318166210AUDIBEL DAVINCI I2000 ITC
00842318166203AUDIBEL DAVINCI I2400 ITC
00842318166197AUDIBEL DAVINCI I1000 CIC
00842318166180AUDIBEL DAVINCI I1200 CIC
00842318166173AUDIBEL DAVINCI I1600 CIC
00842318166166AUDIBEL DAVINCI I2000 CIC
00842318166159AUDIBEL DAVINCI I2400 CIC

Trademark Results [AUDIBEL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AUDIBEL
AUDIBEL
90768794 not registered Live/Pending
Starkey Laboratories, Inc.
2021-06-11
AUDIBEL
AUDIBEL
87872834 5595781 Live/Registered
Starkey Laboratories, Inc.
2018-04-11
AUDIBEL
AUDIBEL
76385936 2672076 Live/Registered
STARKEY LABORATORIES, INC.
2002-03-21
AUDIBEL
AUDIBEL
74181598 1707953 Live/Registered
STARKEY LABORATORIES, INC.
1991-07-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.