Cochlear™ Kanso® 3 Microphone Cover

Basic Information

• Brand Name: Cochlear™ Kanso® 3 Microphone Cover
• Primary DI: 09321502072236
• Version / Model: Black
• Catalog Number: P1967084
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2025-07-07
• Public Version: 1
• Public Version Date: 2025-07-15
• Public Version Status: New
• Public Device Record Key: 63f10016-a5c5-43cb-9bf4-586ee2ede6bd

Device Description

Hearing Implant Accessory

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

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
64180	Cochlear implant system sound processor microphone cover	A device intended to be used as a cover for the sound processor of a cochlear implant system to protect the processor microphones from dirt/debris. It is typically made of plastic material and designed to be clipped onto the top of the sound processor case. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	09321502081627	GS1
Primary	09321502072236	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	225