Home GUDID 05711781002736 Unity 4 / Measure
Primary DI 05711781002736
Brand Unity 4 / Measure
Company Auditdata A/S
Model Talk Forward Operator Headset (2000-1)
Catalog number 100.114
Device description 2000-1 Fitting Unit Audiometer
Published 2024-08-21
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name EWO Audiometer
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EWO Audiometer Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05711781002736 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05711781002736 05711781002736 5711781002736
GMDN Terms# Term, Definition table Term Definition Audiometric/hearing aid tester An electroacoustic device intended to be used for both the evaluation of hearing loss (audiometer function) and the evaluation of hearing aids while worn for optimal amplification [real-ear measurement (REM)]; some types may in addition be used to test hearing aid function when being fitted to the patient. It typically consists of a test box and a control unit that connect to an off-the-shelf computer that runs application software to provide results and graphics (which may be stored in a database). It may be used as an audiometer or real-ear-measurement instrument without the test box.
Regulatory Flags# DUNS number 310385849 Device count 1 Premarket exempt true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05711781004105 3000 Real Ear CA1 Audiometric Headphone 100.064 2026-01-23 05711781004136 3000 Real Ear IN1 Insert Earphone 100.067 2026-01-23 05711781004143 3000 Real Ear BC1 Bone Conductor 100.060 2026-01-23 05711781004150 3000 Real Ear CA1 HF Audiometric Headphone 100.065 2026-01-23 05711781004167 3000 Real Ear SA1 HBA Headphone 100.063 2026-01-23 05711781004174 3000 Real Ear SA1 RE-7 Headphone 100.068 2026-01-23 05711781004204 Measure by Otometrics AUD Base Package 100.421 2025-11-14 05711781004211 Measure by Otometrics AUD-HF & REM & Speech Mapping Package 100.422 2025-11-14 05711781004228 Measure by Otometrics AUD-HF & Wireless REM & Speech Mapping Package 100.423 2025-11-14 05711781004235 Measure by Otometrics AUD & REM & Speech Mapping Package 100.424 2025-11-14 05711781004242 Measure by Otometrics AUD & Wireless REM & Speech Mapping Package 100.425 2025-11-14 05711781004259 Measure by Otometrics US/CA AUD & REM & Speech Mapping (ANSI) Package 100.426 2025-11-14 05711781004266 Measure by Otometrics US/CA AUD & Wireless REM & Speech Mapping (ANSI) P 100.427 2025-11-14 05711781004280 Measure by Otometrics US/CA AUD Base (ANSI) Package 100.428 2025-11-14 05711781004297 Measure by Otometrics - HIT HIT Pro Package 100.450 2025-11-14 05711781004372 Measure by Otometrics - HIT US/CA AUD HIT Pro Package 100.451 2025-11-14 00571178100316 Unity 4 Unity 4 INSITU Package 21031181 2024-08-21 05711781004006 Unity 3 Unity 3 HIT UNIT US package 21044734 2024-10-21 05711781002743 Measure Measure Software (USB stick) 100.115 2024-09-17 05711781003818 Unity 4 / Measure UNITY 4 PROBE MIC US PACKAGE 21031179 2024-09-17
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