GN Hearing

Basic Information

• Brand Name: GN Hearing
• Primary DI: 05708296137428
• Version / Model: 15874200
• Company Name: Gn Hearing A/S
• Labeler DUNS: 306179227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2022-04-08
• Public Version Status: Update
• Public Device Record Key: d91f91ef-12af-45fa-bb7b-da88c8cb0a0a

Device Description

SPEEDLINK UNIT

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
OSM	Hearing aid, air conduction with wireless technology	Ear, Nose, Throat	874.3305	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61462	Hearing aid/implant system programming interface unit	A portable, electrically-powered device intended to facilitate the wireless or wired connection of a hearing aid or implant system component (e.g., sound processor) to a computer for programming of the hearing device with patient-specific settings and sometimes assessment. It typically consists of a small unit attached to the hearing device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708296137428	GS1

Customer Contacts

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