{"publicDeviceRecordKey":"d171009d-a4a6-4b2f-bff3-691aefe2f724","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-11-03T00:00:00.000Z","devicePublishDate":"2018-10-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00850681007153","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"2Mhz Monitoring Transducer - 8 foot","versionModelNumber":"NA-PRB3","catalogNumber":"NA-PRB3","dunsNumber":"078766464","companyName":"Novasignal Corp.","deviceCount":1,"deviceDescription":"The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements.\nThe transducer has the following specifications:\n• 2MHz ± 0.1MHz center frequency\n• 46mm ± 5mm focal length\n• 16mm active diameter\n• Fractional 6dB pulse-echo bandwidth = 60% to 80%\n• Round-trip insertion loss \u003c 6dB\n• Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K160442","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36970","gmdnPTName":"Noninvasive vascular ultrasound system probe","gmdnPTDefinition":"A hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). It may also be used to detect the foetal heartbeat. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ITX","productCodeName":"Transducer, Ultrasonic, Diagnostic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}