Instrumentation Difra 17473

GUDID B516174730

The water caloric stimulator is a device that delivers a stream of water 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. An internal chronometer offers through a second rotary switch the possibility to select the stimulation time. Five stimulation times are available: 20, 30, 40,50 and 60s By default, temperature values are 27°C, 30°C, 37°C and 44°C. Minimal temperature reachable: 3°C over the ambient temperature Maximal temperature reachable: 48°C Water flow: fixed, 350ml/min Timer Requires a water supply and an outlet 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: B516174730
• NIH Device Record Key: 52db553a-80c6-448c-ad9d-badddcaec2e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Instrumentation Difra
• Version Model Number: AquaStar 230V 2.0
• Catalog Number: 17473
• 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: true
• 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

• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter
• Weight: 5 Kilogram
• Height: 11.5 Centimeter
• Depth: 35.5 Centimeter
• Length: 31 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B516174730 [Primary]

FDA Product Code

• ETP: Stimulator, Caloric-Water

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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