{"publicDeviceRecordKey":"9c637132-f76a-450a-8373-5634a11cd6c0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2020-11-19T00:00:00.000Z","devicePublishDate":"2020-05-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B516174850","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Instrumentation Difra","versionModelNumber":"AirStar 2.0","catalogNumber":"17485","dunsNumber":"370173410","companyName":"Instrumentation Difra SA","deviceCount":1,"deviceDescription":"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. \nThe vestibular stimulation of the semicircular canals produces involuntary eye movements.\nThe 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.\nBy default, temperature values are 27°C, 30°C, 44°C and 47°C.\nFive stimulation times are available: 40, 60, 80,100 and 120s\nWarm air caloric stimulator\nMinimal temperature reachable: 5°C over the ambient temperature\nMaximal temperature reachable: 48°C\nAir flow: fixed, from 10 to 13l/min, without ear tip\nTimer\nIntended user: Qualified users, ENT doctors, audiologist, nurses and medical staff trained to the device and to the\ncaloric testing process.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"260.436.1436","phoneExtension":null,"email":"dbscherer@gmail.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34891","gmdnPTName":"Diagnostic caloric vestibular stimulation system","gmdnPTDefinition":"An assembly of devices intended to evaluate a patient’s vestibular function through the application of heat and/or cold stimuli in the form of a stream of air or water into the ear canal, whereby involuntary horizontal eye movements (nystagmus) are produced and measured using a nystagmograph. The procedure may also be referred to as caloric reflex test, and is typically used for assessing a patient's balance system and/or to test for brainstem death. It typically consists of an irrigation system that includes a pump, valves, heaters and regulators to control the rate of flow and temperature of the medium. This device is typically used in an ear/nose/throat (ENT) department.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KHH","productCodeName":"Stimulator, Caloric-Air"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Depth","size":{"unit":"Centimeter","value":"34.5"},"sizeText":null,"sizeString":"Depth: 34.5 Centimeter"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"31"},"sizeText":null,"sizeString":"Length: 31 Centimeter"},{"sizeType":"Height","size":{"unit":"Centimeter","value":"11.5"},"sizeText":null,"sizeString":"Height: 11.5 Centimeter"},{"sizeType":"Weight","size":{"unit":"Kilogram","value":"5"},"sizeText":null,"sizeString":"Weight: 5 Kilogram"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"35"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"55"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}