<?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>fc6a9a51-fe0a-41ef-8298-cd2744bcbda8</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-08-15</publicVersionDate><devicePublishDate>2025-08-07</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>05711117245097</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><identifier><deviceId>05711117230833</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>Sanibel Supply A/S</brandName><versionModelNumber>ER10C-03</versionModelNumber><catalogNumber>8537238</catalogNumber><dunsNumber>306308354</dunsNumber><companyName>Interacoustics A/S</companyName><deviceCount>20</deviceCount><deviceDescription xsi:nil="true"/><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>true</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K930553</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>62133</gmdnCode><gmdnPTName>Audiometric ear tip</gmdnPTName><gmdnPTDefinition>A luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EWO</productCode><productCodeName>Audiometer</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>