Home GUDID 00810126191403 Audina
Primary DI 00810126191403
Brand Audina
Company Audina Hearing Instruments, Inc.
Model INSTAFIT I2 ER R
Device description AUDINA INSTAFIT I2 ER R
Published 2023-01-31
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name ESD Hearing Aid, Air-Conduction, Prescription
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00810126191403 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00810126191403 00810126191403 810126191403 0810126191403
GMDN Terms# Term, Definition table Term Definition Air-conduction hearing aid, canal 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) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. 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. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
Regulatory Flags# DUNS number 606310522 Device count 1 DM exempt true Premarket exempt true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840388201145 STARKEY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201541 STARKEY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201640 AUDIBEL Starkey Laboratories, Inc. ESD 2025-06-25 00840388201657 AUDIBEL Starkey Laboratories, Inc. ESD 2025-06-25 00840388201664 AUDIBEL Starkey Laboratories, Inc. ESD 2025-06-25 00840388201695 NUEAR Starkey Laboratories, Inc. ESD 2025-06-25 00840388201701 NUEAR Starkey Laboratories, Inc. ESD 2025-06-25 00840388201725 MICROTECH Starkey Laboratories, Inc. ESD 2025-06-25 00840388201732 MICROTECH Starkey Laboratories, Inc. ESD 2025-06-25 00840388201763 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201770 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201787 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201794 AUDIGY Starkey Laboratories, Inc. ESD 2025-06-25 00840388201886 AMPLIFON Starkey Laboratories, Inc. ESD 2025-06-25 00840388201909 AMPLIFON Starkey Laboratories, Inc. ESD 2025-06-25 00840388201985 STARKEY Starkey Laboratories, Inc. ESD 2025-06-25 07613389772838 ampli-mini I 3 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772845 ampli-mini I 2 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772920 MEMINI I 4 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 07613389772937 MEMINI I 3 5P CIC-10 NWL PH Sonova AG ESD 2024-11-12 16945936703773 Newsound Xiamen New Sound Technology Co., Ltd. ESD 2024-01-19 00810126191373 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191380 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191397 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191410 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191427 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191434 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191441 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191458 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191465 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31