Home GUDID 00850010429045 EARGO
Primary DI 00850010429045
Brand EARGO
Company Eargo, Inc.
Model 99-0078-001
Catalog number 99-0078-001
Device description EARGO NEO, Replacement Hearing Device, Right
Published 2019-10-14
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name ESD Hearing aid, air conduction
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 00850010429045 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 00850010429045 00850010429045 850010429045 0850010429045
GMDN Terms# Term, Definition table Term Definition Canal air-conduction hearing aid 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -20 Degrees Celsius 50 Degrees Celsius
Regulatory Flags# DUNS number 079865289 Device count 1 DM exempt true Premarket exempt true Lot or batch 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 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 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 00810126191403 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 00810126191472 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191489 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191496 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191502 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191519 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191526 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191533 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191540 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191557 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191564 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191571 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31 00810126191588 Audina Audina Hearing Instruments, Inc. ESD 2023-01-31
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