Home GUDID 05711781004297 Measure by Otometrics - HIT
Primary DI 05711781004297
Brand Measure by Otometrics - HIT
Company Auditdata A/S
Model HIT Pro Package
Catalog number 100.450
Device description 2000 Primus HIT Pro
Published 2025-11-14
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 ETW Calibrator, Hearing Aid / Earphone And Analysis Systems
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ETW Calibrator, Hearing Aid / Earphone And Analysis Systems Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05711781004297 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05711781004297 05711781004297 5711781004297
GMDN Terms# Term, Definition table Term Definition Hearing aid tester, electrical An assembly of electronic reference devices intended to be used by a healthcare provider in a clinical setting to verify the performance of and/or calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, microphone, oscillators, frequency counters, microphone amplifiers, distortion analyser, chart recorder, and a hearing aid test box; some types may include a probe microphone used for real-ear measurement (REM). It does not measure hearing acuity [i.e., it is not an audiometer].
Regulatory Flags# DUNS number 310385849 Device count 1 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label 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 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 05711781002729 Unity 4 / Measure Talk Back Client Microphone (2000-1) 100.113 2024-08-21
Other Devices Sharing Product Codes#