BTE Power Adapter

GUDID 07630016809415

Silver Metallic

Advanced Bionics AG

Cochlear implant system battery pack Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery Cochlear implant/auditory brainstem implant battery
Primary Device ID07630016809415
NIH Device Record Keyfcfd55d1-0b55-4d21-80b5-755e171242b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBTE Power Adapter
Version Model NumberCI-7404-100
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

Operating and Storage Conditions

Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 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 106 KiloPascal
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016809415 [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 Date2015-10-16

On-Brand Devices [BTE Power Adapter]

07630016809422Beige
07630016809415Silver Metallic
07630016809408Dark Sienna Metallic

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