FDA.reportPublic FDA data

GN Otometrics A/S

Primary DI
05713315004131
Brand
GN Otometrics A/S
Company
Natus Medical Denmark ApS
Model
"""AirCal Caloric Stimulator, Extended"
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KHHStimulator, Caloric-Air

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KHHStimulator, Caloric-AirEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713315004131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713315004131057133150041315713315004131

GMDN Terms#

Term, Definition table
TermDefinition
Caloric vestibular-stimulation systemAn assembly of devices intended to apply heat stimuli in the form of a stream of air or water into the ear canal. 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. The stimulation of the semicircular canal produces involuntary eye movements (nystagmus) which are measured using a nystagmograph. It is used for vestibular function testing for assessing the patient's balance system. This device is typically used in an ear/nose/throat (ENT) department.

Sterilization Methods#

Method table
Method

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 DIBrandModelCatalogPublished
05713315009426Madsen Zodiac8-04-163038-04-163032026-06-03
05713315009433Madsen Zodiac8-04-163048-04-163042026-06-03
05713315009457Madsen Zodiac8-04-163068-04-163062026-06-03
05713315009471Madsen Zodiac8-04-163088-04-163082026-06-03
05713315009488Madsen Zodiac8-04-163098-04-163092026-06-03
05713315009501Madsen Zodiac8-04-163118-04-163112026-06-03
05713315009518Madsen Zodiac8-04-163128-04-163122026-06-03
05713315009525Madsen Zodiac8-04-163138-04-163132026-06-03
05713315009532Madsen Zodiac8-04-163148-04-163142026-06-03
05713315009556Madsen Zodiac8-04-163168-04-163162026-06-03
05713315009570Madsen Zodiac8-04-163188-04-163182026-06-03
05713315009402Madsen Zodiac8-04-163012026-06-02
05713315008474Otometrics1085, FACE CUSHION 2 ASM KIT8-35-501002020-06-02
05713315008443Otometrics1085, STRAP ASSEMBLY8-35-342002019-11-20
05713315008467Otometrics1085, FACE PAD ASSEMBLY KIT V28-35-393002020-05-18
05713315003295OtometricsGoggle face cushion kit2019-04-24
05713315005268GN Otometrics A/S1085, GOGGLE HOME KIT2016-09-23
05713315002915GN Otometrics A/SDisposable Diff VEMP Electrode2019-04-01
05713315002649GN Otometrics A/S"Disposable Electrode 24"" Wired Qty 10"2016-09-26
05713315000874GN Otometrics A/SOTOair Bluetooth Dongle2016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250365143065ATMOSATMOS MedizinTechnik GmbH & Co. KGKHH2024-11-27
B516310120Instrumentation Difra SAInstrumentation Difra SAKHH2022-09-28
B516310130Instrumentation Difra SAInstrumentation Difra SAKHH2022-09-28
05713315009235ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009242ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009259ICSNatus Medical Denmark ApSKHH2021-07-06
05713315009266ICSNatus Medical Denmark ApSKHH2021-07-06
05711117199567InteracousticsInteracoustics A/SKHH2021-06-14
B516174810Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
B516174850Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
B516175530Instrumentation DifraInstrumentation Difra SAKHH2020-05-18
05713315002533GN Otometrics A/SNatus Medical Denmark ApSKHH2019-04-24
B51617481Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
B51617485Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
B51617553Instrumentation DifraInstrumentation Difra SAKHH2018-09-17
05713315004124GN Otometrics A/SNatus Medical Denmark ApSKHH2016-09-19