Slim HP 3D Magnet 7

GUDID 00840094499836

7

Advanced Bionics, LLC

Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet Hearing implant system external magnet

• Primary Device ID: 00840094499836
• NIH Device Record Key: 02a17417-e6f1-4c70-8cb7-07060a4df5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Slim HP 3D Magnet 7
• Version Model Number: CI-7525-007
• Company DUNS: 803906382
• Company Name: Advanced Bionics, LLC
• 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: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx
• Phone: 661-362-1400
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius
• 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 Humidity: Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094499836 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-18
• Device Publish Date: 2023-05-10

Devices Manufactured by Advanced Bionics, LLC

• 00840094491007 - AB Remote: 2023-12-11 Support App (Palma)
• 00840094492240 - Target CI: 2023-12-08 Target CI (Version 1.5)
• 00840094448148 - SoundWave™ Professional Suite Software: 2023-11-03 3.1
• 00840094448155 - SoundWave™ Professional Suite Software: 2023-11-03 3.2
• 07630016878275 - Target CI: 2023-11-03
• 00840094413153 - M Zn-Air Battery Pak: 2023-05-18 Blue Ocean
• 00840094413160 - M Zn-Air Battery Pak: 2023-05-18 Sand Beige
• 00840094413177 - M Zn-Air Battery Pak: 2023-05-18 Majesty Purple