AIM™ System

GUDID 07630016862809

Advanced Bionics AG

Laptop/tablet computer
Primary Device ID07630016862809
NIH Device Record Key497ab81d-9639-4124-ac1b-7d38c57128b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIM™ System
Version Model NumberCI-6126
Company DUNS485262658
Company NameAdvanced Bionics AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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 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
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 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016862809 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-07
Device Publish Date2019-05-30

On-Brand Devices [AIM™ System ]

07630016862809CI-6126
07630016864650CI-6126
07630016882944CI-6126
07630016882623CI-6126

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