AB Remote

GUDID 00840094491007

Support App (Palma)

Advanced Bionics, LLC

Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software

• Primary Device ID: 00840094491007
• NIH Device Record Key: 09fef645-97da-4edd-baa8-825978475d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AB Remote
• Version Model Number: CI-6517
• 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: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840094491007 [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: 2023-12-11
• Device Publish Date: 2023-12-01

Devices Manufactured by Advanced Bionics, LLC

• 00840094491007 - AB Remote: 2023-12-11Support App (Palma)
• 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