Bernafon

Basic Information

• Brand Name: Bernafon
• Primary DI: 05711584090435
• Version / Model: 193700
• Company Name: Bernafon AG
• Labeler DUNS: 480002286
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-20
• Public Version: 1
• Public Version Date: 2018-09-20
• Public Version Status: New
• Public Device Record Key: 37e9afd3-8733-4a50-b67e-9f8499c3ac8e

Device Description

CAPTO 7 FW 3.0

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
OSM	Hearing aid, air conduction with wireless technology	Ear, Nose, Throat	874.3305	2
KLW	Masker, tinnitus	Ear, Nose, Throat	874.3400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57884	Hearing aid wireless-fitting computer-aided set	A collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05711584090435	GS1

Customer Contacts

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