Home GUDID 06945936701567 Otofonix
Primary DI 06945936701567
Brand Otofonix
Company Xiamen New Sound Technology Co., Ltd.
Model Otofonix Sona Beige
Published 2020-09-03
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name OSM Hearing Aid, Air Conduction With Wireless Technology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OSM Hearing Aid, Air-Conduction With Wireless Technology, Prescription Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 06945936701567 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06945936701567 06945936701567 6945936701567
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, behind-the-ear A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Regulatory Flags# DUNS number 528181200 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05708296434688 GN Hearing Gn Hearing A/S OSM 2026-09-18 05708296434701 GN Hearing Gn Hearing A/S OSM 2026-09-18 05708296434718 GN Hearing Gn Hearing A/S OSM 2026-09-18 05708296477159 GN ReSound Gn Hearing A/S OSM 2026-09-18 05708296477166 Beltone Gn Hearing A/S OSM 2026-09-18 05708296477173 GN ReSound Gn Hearing A/S OSM 2026-09-18 05708296477180 Beltone Gn Hearing A/S OSM 2026-09-18 05714880250695 Audio Service Ws Audiology Usa, Inc. OSM 2026-09-18 05714880250701 Audio Service Ws Audiology Usa, Inc. OSM 2026-09-18 05714880250718 Audio Service Ws Audiology Usa, Inc. OSM 2026-09-18 05714880250725 Audio Service Ws Audiology Usa, Inc. OSM 2026-09-18 05714880250732 Audio Service Ws Audiology Usa, Inc. OSM 2026-09-18 00840388220580 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220597 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220757 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220764 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220771 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220788 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220795 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220801 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220818 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220825 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220863 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220917 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220955 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388220993 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388221006 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388221013 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388221020 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04 00840388221037 Starkey G Series AI Starkey Laboratories, Inc. OSM 2026-09-04