11223-007

GUDID 09008738501135

Audio Processor

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Partially-implantable middle ear implant system

• Primary Device ID: 09008738501135
• NIH Device Record Key: e7893645-aace-44a1-8c45-da4c3bca46c2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: AP 404 Gray
• Catalog Number: 11223-007
• Company DUNS: 300764032
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com
• Phone: +1(888)633-3524
• Email: implants.us@medel.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008738501135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990052

FDA Product Code

• MPV: Implant, Hearing, Active, Middle Ear, Partially Implanted

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-03
• Device Publish Date: 2014-09-22

Devices Manufactured by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

• 09008737383015 - SONNET 3 BabyWear Kit (DL) White: 2025-03-07 Audio Processor Accessory
• 09008737383022 - SONNET 3 BabyWear Kit (DL) Beige: 2025-03-07 Audio Processor Accessory
• 09008737383039 - SONNET 3 BabyWear Kit (DL) Nordic Gray: 2025-03-07 Audio Processor Accessory
• 09008737385842 - SONNET 3 BabyWear Kit (DL) Black: 2025-03-07 Audio Processor Accessory
• 09008737412180 - FineTuner Echo: 2025-03-06 Audio Processor Remote Control
• 09008737413415 - AudioKey 3: 2025-03-06 Mobile application (iOS)
• 09008737413422 - AudioKey 3: 2025-03-06 Mobile application (Android)
• 09008737434830 - SONNET 3 Kit (Me1710) BAT FTE Anthracite: 2025-03-06 Audio Processor Kit