Cochlear™ Aqua+ for Kanso®

Basic Information

• Brand Name: Cochlear™ Aqua+ for Kanso®
• Primary DI: 09321502034289
• Version / Model: Z594543
• Catalog Number: Z594543
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 4
• Public Version Date: 2021-08-26
• Public Version Status: Update
• Public Device Record Key: 80817b1c-9102-4c9c-87d9-06334249a49a

Device Description

N/A

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61152	Cochlear implant system waterproof kit	A collection of non-sterile devices intended to be used with a cochlear implant system to protect the externally worn components in wet and/or rugged environments (e.g. for swimming, showering). The set typically consists of a sound processor case, waterproof microphone, and a connecting cable. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502034289	GS1
Unit of Use	09321502040518	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P970051	143