UHP Cable BTE

GUDID 07630016812224

Beige

Advanced Bionics AG

Cochlear implant system coil cable

Primary Device ID	07630016812224
NIH Device Record Key	b8ea9698-9594-4287-8fba-997d4b73dd62
Commercial Distribution Status	In Commercial Distribution
Brand Name	UHP Cable BTE
Version Model Number	CI-5410-305
Company DUNS	485262658
Company Name	Advanced Bionics AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter
Length	30 Centimeter

Operating and Storage Conditions

Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal
Storage Environment Temperature	Between -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Humidity	Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure	Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630016812224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P960058

FDA Product Code

MCM	IMPLANT, COCHLEAR

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-10-16

On-Brand Devices [UHP Cable BTE]

07630016812224	Beige
07630016812217	Beige
07630016812200	Beige
07630016812194	Beige
07630016812187	Beige
07630016812170	Black
07630016812163	Black
07630016812156	Black
07630016812149	Black
07630016812132	Black
07630016812125	Silver Metallic
07630016812118	Silver Metallic
07630016812101	Silver Metallic
07630016812095	Silver Metallic
07630016812088	Silver Metallic