Home GUDID 05711781004143 3000 Real Ear
Primary DI 05711781004143
Brand 3000 Real Ear
Company Auditdata A/S
Model BC1 Bone Conductor
Catalog number 100.060
Device description BC1 Bone Conductor (2000-1)
Published 2026-01-23
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 05711781004143 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05711781004143 05711781004143 5711781004143
GMDN Terms# Term, Definition table Term Definition Auditory cranial bone vibrator An electromechanical transducer intended to produce the sensation of hearing by vibrating the cranial bones. It can be used as an output device with an audiometer to measure bone-conduction hearing thresholds, and thus serve as an adjunct to air-conduction testing with conventional earphones. Comparison of the results enables the clinician to distinguish hearing loss attributable to the external or middle ear (conductive loss) from the inner ear (sensory loss). In addition, this device may be used to provide output for a hearing aid for patients who cannot wear an earmould.
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 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 05711781002729 Unity 4 / Measure Talk Back Client Microphone (2000-1) 100.113 2024-08-21
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