Instrumentation Difra 17485

GUDID B516174850

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.

Instrumentation Difra SA

Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system Caloric vestibular-stimulation system

• Primary Device ID: B516174850
• NIH Device Record Key: 9c637132-f76a-450a-8373-5634a11cd6c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra
• Version Model Number: AirStar 2.0
• Catalog Number: 17485
• Company DUNS: 370173410
• Company Name: Instrumentation Difra SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com
• Phone: 260.436.1436
• Email: dbscherer@gmail.com

Device Dimensions

• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram
• Depth: 34.5 Centimeter
• Length: 31 Centimeter
• Height: 11.5 Centimeter
• Weight: 5 Kilogram

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516174850 [Primary]

FDA Product Code

• KHH: Stimulator, Caloric-Air

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-26
• Device Publish Date: 2020-05-18

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