Cochlear™ Custom Sound® Suite

Basic Information

• Brand Name: Cochlear™ Custom Sound® Suite
• Primary DI: 09321502044936
• Version / Model: P1487131
• Catalog Number: P1487131
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-22
• Public Version: 4
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: acff55c4-b865-4efb-82ca-017ae4b9710b

Device Description

Version 5.2

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: Yes
• 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
60211	Audiometric/hearing device software	A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502044936	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	182