GN ReSound

Basic Information

• Brand Name: GN ReSound
• Primary DI: 05708296137299
• Version / Model: 18157600
• Company Name: Gn Hearing A/S
• Labeler DUNS: 306179227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8b2811ee-3c52-4d0e-99e9-2e528a101d6e

Device Description

INTEGRD FM01 ADAPT HA,RS,NANO

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
57961	Hearing aid enhanced audio device, teaching-environment	A collection of battery-powered devices designed to be worn by a person (typically a child) wearing a compatible hearing aid to enhance the sound quality they receive by reducing background noise and/or room reverberation potentially found in a teaching environment (e.g., a school classroom). It uses a set frequency modulation (FM) between a transmitter worn by the speaker (e.g., a microphone worn be the teacher) and the FM receiver worn by the user. It typically consists of the FM receiver, a neck induction loop that emits the sound locally to the hearing aid, a battery charger, and various cables enabling connection to digital music devices.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708296137299	GS1

Customer Contacts

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