Audio Processor 404 dark brown

Basic Information

• Brand Name: Audio Processor 404 dark brown
• Primary DI: 09008738501128
• Version / Model: 11223-006
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-22
• Public Version: 5
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 51257749-9b09-4420-8694-9cdcdfc69774
• Distribution End Date: 2016-12-23

Device Description

Audio Processor

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47369	Partially-implantable middle ear implant system sound processor	The non-sterile external portion of a partially-implantable middle ear implant system that typically consists of a battery-powered microphone, signal analysis and filtering unit, radio-frequency (RF) modulator and amplifier, and an RF transmitter and antenna. These components receive sound waves from the environment, convert them into electrical signals (radio waves), and transmit the signals to the implantable portion of the system which activates the auditory pathway by vibrating the ossicles (middle ear bones).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008738501128	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P990052	003
P990052	004
P990052	006
P990052	011
P990052	015
P990052	016

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 149 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -40 – 65 Degrees Celsius