Nucleus® 7 Aqua+ Z544583

GUDID 09321502036214

The Nucleus 7 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of 3 meters (9 ft and 9 in) for up to 2 hours. This water protection only applies when you use a Cochlear Standard Rechargeable Battery Module.

COCHLEAR LIMITED

Cochlear implant system waterproof kit

• Primary Device ID: 09321502036214
• NIH Device Record Key: 68345445-2ef5-4e44-a1fa-065148d3eaa4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nucleus® 7 Aqua+
• Version Model Number: Z544583
• Catalog Number: Z544583
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 2
• 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: false
• Manufacturing Date: true
• 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(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502036214 [Primary]
GS1	09321502041638 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970051

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: 4
• Public Version Date: 2021-04-12
• Device Publish Date: 2017-06-28

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• 09321502013369 - Nucleus: 2025-03-07 Cochlear Nucleus CI500 Series Non-Sterile Silicone Implant Template
• 09321502018395 - Nucleus: 2025-03-07 CI500 Series Non-Magnetic Plug
• 09321502024655 - Nucleus: 2025-03-07 Cochlear Nucleus LiteWear Case
• 09321502046152 - Cochlear: 2025-03-07 Cochlear Osia OSI200 Implant
• 09321502026895 - Nucleus: 2025-02-18 NUCLEUS AQUA COIL, 6CM
• 09321502014557 - Cochlear Surgical Instrument Upgrade Kit: 2024-11-15