Neptune™ Cable for AquaMic

GUDID 07630016811234

White

Advanced Bionics AG

Cochlear implant system coil cable
Primary Device ID07630016811234
NIH Device Record Key61c04cd1-c332-49fc-9545-262d54efd95d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeptune™ Cable for AquaMic
Version Model NumberCI-5414-503
Company DUNS485262658
Company NameAdvanced Bionics AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx

Device Dimensions

Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter
Length46 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 130 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016811234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-20

On-Brand Devices [Neptune™ Cable for AquaMic]

07630016811265White
07630016811258White
07630016811241White
07630016811234White
07630016811227White
07630016811210White
07630016811081Black
07630016811074Black
07630016811067Black
07630016811050Black
07630016811043Black
07630016811036Black

Trademark Results [Neptune]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NEPTUNE
NEPTUNE
98753310 not registered Live/Pending
Neptune Cigars, Inc.
2024-09-16
NEPTUNE
NEPTUNE
98610675 not registered Live/Pending
TETRA Technologies Inc.
2024-06-20
NEPTUNE
NEPTUNE
98117882 not registered Live/Pending
Neptune Beverage LLC
2023-08-04
NEPTUNE
NEPTUNE
98103044 not registered Live/Pending
Bolt Graphics, Inc.
2023-07-26
NEPTUNE
NEPTUNE
97741453 not registered Live/Pending
Peerless Industries, Inc.
2023-01-04
NEPTUNE
NEPTUNE
97722908 not registered Live/Pending
Early Morning LLC
2022-12-19
NEPTUNE
NEPTUNE
97714130 not registered Live/Pending
Pioneer Distributors, LLC
2022-12-12
NEPTUNE
NEPTUNE
97655602 not registered Live/Pending
OneForNeptune, Inc.
2022-10-31
NEPTUNE
NEPTUNE
97645242 not registered Live/Pending
Aristocrat Technologies, Inc.
2022-10-24
NEPTUNE
NEPTUNE
97452923 not registered Live/Pending
Lenovo Enterprise Solutions (Singapore)Pte. Ltd.
2022-06-10
NEPTUNE
NEPTUNE
97441808 not registered Live/Pending
Keyston Bros.
2022-06-03
NEPTUNE
NEPTUNE
97370745 not registered Live/Pending
GS Medical Co., Ltd.
2022-04-19

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