{"publicDeviceRecordKey":"c4cdb876-44d2-40ec-8e95-cc8857d740ad","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2020-09-02T00:00:00.000Z","devicePublishDate":"2020-06-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033003267684","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"78033003267683","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"F9010SSC ","catalogNumber":"F9010SSC ","dunsNumber":"439770017","companyName":"FIAB SPA","deviceCount":4,"deviceDescription":"Reusable peripheral electrodes for ECG, 31.5x22mm dimensions, have features that make them absolutely reliable during signal recording with all  different  ECG  recorders  on  the  market.  The  metallic  part  is  silver  coated  (Ag/AgCl)  allowing  a  safe  and  clear  signal  transmission. F9010SSC thanks to screw and snap connections, can be tapped to all ECG recorders and monitors both with plug and snap. To be used with fasten belts.The product is Latex-free and Nickel-free.","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":[]}}