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Instrumentation Difra

FDA UDI

Class I (US FDA UDI)

by Instrumentation Difra SA

Identity

Trade Name
Instrumentation Difra FDA UDI
Generic Name
Diagnostic caloric vestibular stimulation system FDA UDI
Device Name
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 (tympanic membrane perforation, …), when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22°C. Cool and warm air caloric stimulator Minimal temperature reachable: 10°C with water temperature in glass jar below 50°C Maximal temperature reachable: 49,8°C Air flow: fixed, from 8 to 10l/min, without ear tip Timer: Five stimulation times are available: 40, 60, 80,100 and 120s Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. Glass jar with connection for demineralized water, holder and connections FDA UDI
Model / Reference
CoolStar 115V 3.0 FDA UDI
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 (tympanic membrane perforation, …), when water inlet and outlet are not available in the examination room and when ambient room temperature exceeds 22°C. Cool and warm air caloric stimulator Minimal temperature reachable: 10°C with water temperature in glass jar below 50°C Maximal temperature reachable: 49,8°C Air flow: fixed, from 8 to 10l/min, without ear tip Timer: Five stimulation times are available: 40, 60, 80,100 and 120s Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. Glass jar with connection for demineralized water, holder and connections FDA UDI

Identifiers

Catalog Number
17553 FDA UDI
Primary DI / UDI-DI
B51617553 FDA UDI
FDA Product Code
KHH FDA UDI
GMDN Term
Diagnostic caloric vestibular stimulation system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.1800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 11.5 Centimeter FDA UDI
Length — 31 Centimeter FDA UDI
Depth — 45.5 Centimeter FDA UDI
Weight — 5 Kilogram FDA UDI

Category: Diagnostic caloric vestibular stimulation system

Instrumentation Difra by Instrumentation Difra SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic caloric vestibular stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Instrumentation Difra SA

Sources (1)

  • FDA UDI 6e18f423-a3b8-4ef8-963d-b33310a5a009 37 fields · synced May 31, 2026