AudioStream Battery Pack Cover black

Basic Information

• Brand Name: AudioStream Battery Pack Cover black
• Primary DI: 09008737372149
• Version / Model: 37214
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-06
• Public Version: 2
• Public Version Date: 2023-02-01
• Public Version Status: Update
• Public Device Record Key: 57050f4c-7353-46b7-9044-24ece67d344c

Device Description

Audio Processor Battery Pack Cover

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
MCM	Implant, Cochlear	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60259	Hearing aid/implant system functionality-enhancing device	An electrically-powered device designed to use a wired or wireless connection to a hearing aid (e.g., bone-conduction) or hearing implant system (e.g., cochlear, bone-conduction, partially-implantable middle ear) sound processor to enhance its functionality and/or sound quality [e.g., enable transmission from a multimedia device (e.g., computer, phone, mp3 player) to the hearing device]. It is typically a transmitter/receiver in the form of a microphone, an audio jack, room loop receiver/booster, small attachment and/or a wireless connection receiver. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737372149	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000025	117

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -29 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20.2 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 32 – 122 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal