Home GUDID 05713315009266 ICS
Primary DI 05713315009266
Brand ICS
Company Natus Medical Denmark ApS
Model 8-04-13330
Device description AirCal Caloric Stimulator, Extended (Extended length - 4m)
Published 2021-07-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KHH Stimulator, Caloric-Air
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KHH Stimulator, Caloric-Air Ear, Nose, Throat 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05713315009266 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05713315009266 05713315009266 5713315009266
GMDN Terms# Term, Definition table Term Definition Diagnostic caloric vestibular stimulation system An assembly of devices intended to evaluate a patient’s vestibular function through the application of heat and/or cold stimuli in the form of a stream of air or water into the ear canal, whereby involuntary horizontal eye movements (nystagmus) are produced and measured using a nystagmograph. The procedure may also be referred to as caloric reflex test, and is typically used for assessing a patient's balance system and/or to test for brainstem death. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. This device is typically used in an ear/nose/throat (ENT) department.
Regulatory Flags# DUNS number 306633756 Device count 1 Premarket exempt 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 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 05713315009587 Madsen Zodiac 8-04-16319 8-04-16319 2026-06-04 05713315009594 Madsen Zodiac 8-04-16320 8-04-16320 2026-06-04
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