Home GUDID 05713315000621 GN Otometrics A/S
Primary DI 05713315000621
Brand GN Otometrics A/S
Company Natus Medical Denmark ApS
Model Headset Monitoring
Published 2016-09-19
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 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 05713315000621 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05713315000621 05713315000621 5713315000621
GMDN Terms# Term, Definition table Term Definition Tone audiometer, semi-automated An electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. The device automatically produces tones that sweep the audiometric scale while the patient controls intensity, typically by pressing a button, when the tone cannot be heard. The device also records the patient's responses. This device may have the capacity to present a fixed frequency or a steadily changing frequency. It may also provide both continuous and pulsed tone outputs.
Regulatory Flags# DUNS number 306633756 Device count 1 Premarket exempt true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05713315008610 Natus 8-31-200 8-31-200 2020-12-16 05713315008627 Natus 8-31-19002 8-31-19002 2020-12-16 05713315000713 GN Otometrics A/S Patient Responder (Red) 8-31-190 2016-09-19 05713315009051 Natus 8-62-45300 8-62-45300 2021-04-12 05713315008689 Natus 1053 Freefit Charger 8-62-39303 2021-01-04 05713315005848 GN Otometrics A/S Probe Tube Holder mk2 8-62-60800 2019-04-24 05713315000874 GN Otometrics A/S OTOair Bluetooth Dongle 8-62-41503 2016-09-19 05713315001055 GN Otometrics A/S FreeFit REM probe 8-69-39203 2016-09-19 05713315001192 GN Otometrics A/S PMM RECD Probe Short 8-69-39207 2016-09-19 05713315001208 GN Otometrics A/S PMM RECD Probe Long 8-69-39208 2016-09-19 05713315001215 GN Otometrics A/S PMM RECD Probe Bin Long 8-69-39209 2016-09-19 05713315001222 GN Otometrics A/S PMM RECD Probe Bin Short 8-69-39210 2016-09-19 05713315001246 GN Otometrics A/S RECD Eartip Kit 1-25-13904 2016-09-19 05713315001253 GN Otometrics A/S RECD Fitting Kit 8-62-49000 2016-09-19 05713315001277 GN Otometrics A/S SoundHub 100 8-62-42300 2016-09-26 05713315003301 GN Otometrics A/S REM Test tubes, 1.1mm (50 pcs.) 8-62-35100 2018-07-31 05713315004100 GN Otometrics A/S Aurical FreeFit, Complete Solution 8-04-11808 2016-09-19 05713315004117 GN Otometrics A/S Aurical FreeFit, Complete Solution 8-62-49100 2016-09-19 05713315005701 GN Otometrics A/S REM Tube with ruler 8-62-61000 2018-11-06 05713315008184 GN Otometrics A/S OTOair 2 Bluetooth Dongle 8-62-64900 2019-03-18
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