<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>65b3b1a9-aa17-49d6-8c62-64efd1066b11</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2020-08-28</publicVersionDate><devicePublishDate>2020-06-13</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08033003263440</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier><identifier><deviceId>78033003263449</deviceId><deviceIdType>Unit of Use</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>NA</brandName><versionModelNumber>F9002SSC</versionModelNumber><catalogNumber>F9002SSC</catalogNumber><dunsNumber>439770017</dunsNumber><companyName>FIAB SPA</companyName><deviceCount>6</deviceCount><deviceDescription>Reusable praecordial suction chest electrodes for ECG, ball diameter Ø 25mm and rubber ring diameter Ø 24mm. F9002SSC 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. The rings are made of rubber to improve patient’s comfort. 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,  4mm hole with screw and snap.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+39 0558497943</phone><phoneExtension xsi:nil="true"/><email>quality@fiab.it</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>42489</gmdnCode><gmdnPTName>Electrocardiographic electrode, reusable</gmdnPTName><gmdnPTDefinition>A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient&apos;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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DRX</productCode><productCodeName>Electrode, Electrocardiograph</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="50"/><storageHandlingLow unit="Degrees Celsius" value="0"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="80"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="20"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>