Home GUDID 05713315000713 GN Otometrics A/S
Primary DI 05713315000713
Brand GN Otometrics A/S
Company Natus Medical Denmark ApS
Model Patient Responder (Red)
Catalog number 8-31-190
Device description Patient Responder (Red)
Published 2016-09-19
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use false 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 05713315000713 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05713315000713 05713315000713 5713315000713
GMDN Terms# Term, Definition table Term Definition Tone audiometer An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone intensity and frequency either by a computer or manually, and displays/records the patient's responses, typically in the form of an audiogram. It may include a bone vibrator for direct inner-ear stimulation.
Regulatory Flags# DUNS number 306633756 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 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 00571331500960 Madsen Zodiac 8-04-16321 8-04-16321 2026-06-04
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