{"publicDeviceRecordKey":"5db41dfd-2bc1-47fe-bba3-5fb755adb74b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2020-11-11T00:00:00.000Z","devicePublishDate":"2020-06-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033003263297","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"78033003263296","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"F9016PLUS","catalogNumber":"F9016PLUS","dunsNumber":"439770017","companyName":"FIAB SPA","deviceCount":6,"deviceDescription":"Reusable praecordial suction chest electrodes for ECG, metallic part Ø 30mm and ball diameter Ø 33mm. F9016PLUS model has  features that make it absolutely reliable during signal recording with all different ECG  devices on the market. The metallic part is silver coated (Ag/AgCl) allowing a safe and clear signal transmission. FIAB suction chest electrodes thanks to screw and clip connections, can be tapped to all ECG devices and monitors with patient cables which have plug or snap connections. The product is Latex-free and Nickel-free. \n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+39 0558497943","phoneExtension":null,"email":"quality@fiab.it"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"42489","gmdnPTName":"Electrocardiographic electrode, reusable","gmdnPTDefinition":"A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DRX","productCodeName":"Electrode, Electrocardiograph"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"50"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"0"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Atmospheric Pressure","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"80"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"20"},"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":[]}}