Naida CI Q90 Acoustic Earhook

Basic Information

• Brand Name: Naida CI Q90 Acoustic Earhook
• Primary DI: 00840094489684
• Version / Model: CI-5850-004
• Company Name: Advanced Bionics, LLC
• Labeler DUNS: 803906382
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-13
• Public Version: 1
• Public Version Date: 2023-01-23
• Public Version Status: New
• Public Device Record Key: 878f9477-5f19-45fe-9e8e-0ed053dd42c5

Device Description

Right Size 2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
62901	Cochlear implant/auditory brainstem implant sound processor speaker	A small device designed to be attached to the sound processor of a cochlear implant or auditory brainstem implant system and extended into the external ear canal to function as a speaker providing amplified acoustic low-frequency sound to the eardrum, as a conjunct to the electrical input to the implant. It is intended for patients with improvable low-frequency hearing and is typically made of synthetic polymer materials with metallic components. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	07630016854743	GS1
Primary	00840094489684	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P960058	122

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal