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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 tips 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. By default, temperature values are 27°C, 30°C, 44°C and 47°C. Five stimulation times are available: 40, 60, 80,100 and 120s Warm air caloric stimulator Minimal temperature reachable: 5°C over the ambient temperature Maximal temperature reachable: 48°C Air flow: fixed, from 10 to 13l/min, without ear tip Timer Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. FDA UDI
Model / Reference
AirStar 2.0 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 tips 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. By default, temperature values are 27°C, 30°C, 44°C and 47°C. Five stimulation times are available: 40, 60, 80,100 and 120s Warm air caloric stimulator Minimal temperature reachable: 5°C over the ambient temperature Maximal temperature reachable: 48°C Air flow: fixed, from 10 to 13l/min, without ear tip Timer Intended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the caloric testing process. FDA UDI

Identifiers

Catalog Number
17485 FDA UDI
Primary DI / UDI-DI
B51617485 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

No

FDA UDI

Dimensions & Sizes

Size
Depth — 34.5 Centimeter FDA UDI
Length — 31 Centimeter FDA UDI
Height — 11.5 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 f41d105f-d882-42e9-9b08-a85dea04dd96 37 fields · synced Jun 6, 2026