Instrumentation Difra

Primary DI
B516175530
Brand
Instrumentation Difra
Company
Instrumentation Difra SA
Model
CoolStar 115V 3.0
Catalog number
17553
Device description
The air caloric stimulator is a device that delivers a stream of air to the ear canal at controlled rates of flow and temperature and that is intended for vestibular function testing of a patient's body balance system. The vestibular stimulation of the semicircular canals produces involuntary eye movements. The handle is equipped with an otoscope head where a disposable ear tip can be fixed for easy management of hygiene. The otoscope handle provides also a magnifying glass and integrated light to inspect the ear canal and the tympanic membrane without obstructing the stimulation. CoolStar is ideal when water can not be used for stimulation , when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22 C.
Published
2020-05-18
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
B516175530PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth45.5Centimeter
Height11.5Centimeter
Length31Centimeter
Weight5Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
260.436.1436dbscherer@gmail.com

Regulatory Flags#

DUNS number
370173410
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B516327270Instrumentation Difra SANysStar PRO327272026-03-09
B516325950Instrumentation Difra SAHeadStar V3.0325952025-03-12
B516326290Instrumentation Difra SAHeadStar V3.0326292025-03-12
B516326380Instrumentation Difra SAHeadStar V3.0326382025-03-12
B516308640Instrumentation Difra SANysStar II 308642024-08-19
B516320980Instrumentation Difra SAHeadStar V2.0320982024-01-31
B516311790Instrumentation Difra SANysStar II with VOR 311792022-11-02
B516310120Instrumentation Difra SAAirStar 230V310122022-09-28
B516310130Instrumentation Difra SAAirStar 115V310132022-09-28
B516223150Instrumentation DifraIdeas III223152021-06-28
B516174730Instrumentation DifraAquaStar 230V 2.0174732020-05-18
B516174810Instrumentation DifraCoolStar 230V 3.0174812020-05-18
B516174850Instrumentation DifraAirStar 2.0174852020-05-18
B516175500Instrumentation DifraAquaStar 115V 2.0175502020-05-18
B51617473Instrumentation DifraAquaStar 230V 2.0174732018-09-17
B51617481Instrumentation DifraCoolStar 230V 3.0174812018-09-17
B51617485Instrumentation DifraAirStar 2.0174852018-09-17
B51617550Instrumentation DifraAquaStar 115V 2.0175502018-09-17
B51617553Instrumentation DifraCoolStar 115V 3.0175532018-09-17
B516220900Instrumentation DifraVIDEOSTAR220902020-06-18

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
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
05713315004131GN Otometrics A/SNatus Medical Denmark ApSKHH2016-09-19