BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

AudioLink XT Core Kit

DI: 09008737458904 · Model: 45890 · Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: AudioLink XT Core Kit
Primary DI: 09008737458904
Version / Model: 45890
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: 2025-02-26
Public Version: 3
Public Version Date: 2026-03-23
Public Version Status: Update
Public Device Record Key: bd90c52a-422f-4eee-93ca-ecb5fc73372f

Device Description

Audio Processor Accessory

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: 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
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	09008737458904	GS1

Customer Contacts

Phone: 1-888-633-3524
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P000025	109

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 45 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -4 – 113 Degrees Fahrenheit
Type: Handling Environment Temperature
Temperature Range: 0 – 40 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: 32 – 104 Degrees Fahrenheit
Type: Storage Environment Humidity
Temperature Range: 10 – 93 Percent (%) Relative Humidity
Type: Handling Environment Humidity
Temperature Range: 10 – 93 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal