<?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>bd78d570-cca2-478a-9e3f-7eb57ccd9a10</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-06-22</publicVersionDate><devicePublishDate>2023-06-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08033860016111</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></identifiers><brandName>BIOPSYBELL SRL</brandName><versionModelNumber>EASY BREATH</versionModelNumber><catalogNumber>BK008BN</catalogNumber><dunsNumber>438746708</dunsNumber><companyName>BIOPSYBELL SRL</companyName><deviceCount>1</deviceCount><deviceDescription>TRACHEOSTOMY HUMIDIFIER (HME)</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</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>false</rx><otc>false</otc><contacts><customerContact><phone>+39053527850</phone><phoneExtension xsi:nil="true"/><email>support@biopsybell.it</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35530</gmdnCode><gmdnPTName>Heat/moisture exchanger, single-use</gmdnPTName><gmdnPTDefinition>A one-piece, canister-like device that connects in-line with a patient&apos;s artificial airway [e.g., an endotracheal (ET) tube], to capture the patient&apos;s exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat &amp; moisture exchanger (HME) or an &quot;artificial nose&quot;, it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>BYD</productCode><productCodeName>Condenser, Heat And Moisture (Artificial Nose)</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>