Nucleus

Basic Information

• Brand Name: Nucleus
• Primary DI: 09321502022644
• Version / Model: Z286003
• Catalog Number: Z286003
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 7
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 112528f6-11f0-448e-bdf2-04ae30deb1bd

Device Description

Cochlear Nucleus Aqua Accessory (5)

Device Characteristics

• Single Use: Yes
• 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
61151	Hearing implant system sound processor case, reusable	A container intended to be used to house and protect a hearing implant system (e.g., cochlear implant, auditory brainstem implant) sound processor (not included) from water and particulates, enabling a patient to use it in wet and rugged environments (e.g., for swimming, showering). It is typically made of waterproof and dustproof synthetic polymer materials, with a watertight seal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502022644	GS1
Unit of Use	09321502031066	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	091