Instrumentation Difra SA 31013

GUDID B516310130

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

Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system Diagnostic caloric vestibular stimulation system

• Primary Device ID: B516310130
• NIH Device Record Key: c78c184d-0ad8-4e67-93fc-7bdf0cdae01d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra SA
• Version Model Number: AirStar 115V
• Catalog Number: 31013
• 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
• 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
• 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage 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
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516310130 [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: 2022-10-06
• Device Publish Date: 2022-09-28

On-Brand Devices [Instrumentation Difra SA]

• B516310130: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B516310120: The air caloric stimulator is a device that delivers a stream of air to the ear canal at control
• B516311790: The videonystagmography performed by a camera and infra red light measures and records the eye m
• B516320980: The videonystagmography performed by a camera and infra red light measures and records the eye m