Home GUDID 06945936705688 NewSound
Primary DI 06945936705688
Brand NewSound
Company Xiamen New Sound Technology Co., Ltd.
Model Primo DR6491
Published 2026-06-02
Public version status New
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, Prescription
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 06945936705688 Primary GS1 0 16945936705685 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 06945936705688 06945936705688 6945936705688 16945936705685 16945936705685
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 2 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 05714880288117 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288124 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288131 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288148 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288155 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288162 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288179 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880288186 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297508 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297515 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297522 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297539 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297546 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297553 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297560 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297577 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297928 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297935 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297942 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297959 SIGNIA Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297966 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297973 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297980 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 05714880297997 CONNEXX Ws Audiology Usa, Inc. OSM 2026-07-16 06945936705701 QuietlyBold Xiamen New Sound Technology Co., Ltd. OSM 2026-06-09 05714880295719 SIGNIA Ws Audiology Usa, Inc. OSM 2026-06-08 05714880295726 SIGNIA Ws Audiology Usa, Inc. OSM 2026-06-08 05714880295733 SIGNIA Ws Audiology Usa, Inc. OSM 2026-06-08 05714880295740 SIGNIA Ws Audiology Usa, Inc. OSM 2026-06-08 05714880295788 SIGNIA Ws Audiology Usa, Inc. OSM 2026-06-08