Nucleus

Basic Information

• Brand Name: Nucleus
• Primary DI: 09321502009560
• Version / Model: S50779
• Catalog Number: S50779
• Company Name: COCHLEAR LIMITED
• Labeler DUNS: 750551194
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 5
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: 9444d1a4-57c1-4994-bdaa-83fa25d0376c

Device Description

FREEDOM PROCESSING UNIT, PEARL BLUE

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
47374	Cochlear implant/auditory brainstem implant sound processor	An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09321502009560	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P970051	028

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius