Home GUDID 05708296231027 GN Hearing
Primary DI 05708296231027
Brand GN Hearing
Company Gn Hearing A/S
Model 21945591
Device description EB,ENHEB10,L,BGE
Published 2024-04-12
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
OTC true Product Codes# Code, Name table Code Name QDD Self-fitting Air-Conduction Hearing Aid, Prescription
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QDD Self-Fitting Air-Conduction Hearing Aid, Prescription Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05708296231027 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05708296231027 05708296231027 5708296231027
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, in-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 miniature microphone, amplifier, and speaker (receiver) contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)]. 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. The device is used for mild to severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Regulatory Flags# DUNS number 306179227 Device count 1 Premarket exempt true Serial number true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00850010429205 Eargo RX Eargo, Inc. QDD 2024-06-17 00850010429274 Eargo RX Eargo, Inc. QDD 2024-06-17 05708296231010 GN Hearing Gn Hearing A/S QDD 2024-04-12 05708296231034 GN Hearing Gn Hearing A/S QDD 2024-04-12 05708296231041 GN Hearing Gn Hearing A/S QDD 2024-04-12 05708296237944 GN Hearing Gn Hearing A/S QDD 2024-04-12 05708296237951 GN Hearing Gn Hearing A/S QDD 2024-04-12 05708296237968 GN Hearing Gn Hearing A/S QDD 2024-04-12 05708296237975 GN Hearing Gn Hearing A/S QDD 2024-04-12 05714880182781 Sony Ws Audiology Usa, Inc. QDD 2023-05-30 05714880182750 Sony Ws Audiology Usa, Inc. QDD 2022-12-20 05708296260775 GN Hearing Gn Hearing A/S QDD 2022-12-08 05708296260782 GN Hearing Gn Hearing A/S QDD 2022-12-08 05708296260799 GN Hearing Gn Hearing A/S QDD 2022-12-08 00850022464645 Lexie Hearing HEARX GROUP (PTY) LTD QDD 2022-10-05 00850022464577 Lexie Hearing HEARX GROUP (PTY) LTD QDD 2022-10-05 10850022464642 Lexie Hearing HEARX GROUP (PTY) LTD QDD 2022-10-05 05714880182743 Sony Ws Audiology Usa, Inc. QDD 2022-09-12 00850022464638 Lexie B2, Powered by Bose HEARX GROUP (PTY) LTD QDD 2022-09-09 00850022464492 Lexie B1, Powered by Bose HEARX GROUP (PTY) LTD QDD 2022-08-01 05708296228706 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296228713 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296233656 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296237609 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296238040 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296238057 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296238064 GN Hearing Gn Hearing A/S QDD 2022-07-08 05708296238071 GN Hearing Gn Hearing A/S QDD 2022-07-08 00328785002911 Braun KAZ USA, INC. QDD 2022-06-02 05708296237883 GN Hearing Gn Hearing A/S QDD 2022-04-04
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