<?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>26b19d16-ef22-43ad-a2c9-8bb6e16394ff</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-10-30</publicVersionDate><devicePublishDate>2023-10-20</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00810040133992</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>00810040134005</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>Safe N Simple</brandName><versionModelNumber>SNS7822134</versionModelNumber><catalogNumber>SNS7822134</catalogNumber><dunsNumber>807812412</dunsNumber><companyName>SAFE N&apos; SIMPLE LLC</companyName><deviceCount>5</deviceCount><deviceDescription>5&quot; x 5&quot; 2-Piece Wafer Extended Wear Convex with Tape Collar Beige 45mm 1 3/4&quot; Flange 7/8&quot; Pre Cut Stoma Opening
</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>true</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>true</otc><contacts><customerContact><phone>2482144877</phone><phoneExtension xsi:nil="true"/><email>amy@sns-medical.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>48158</gmdnCode><gmdnPTName>Intestinal ostomy base plate, convex</gmdnPTName><gmdnPTDefinition>A non-sterile device designed with a convex surface intended to be applied and adhered to peristomal skin to facilitate correct positioning and anchorage of the flange of an intestinal ostomy bag (i.e., one-piece or exchangeable two-piece/multiple piece) and to protect the area from bodily waste contaminants. The convexity of the device is used to improve peristomal skin contact of a flush stoma or more typically a recessed stoma. It is typically self-applied by the patient. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EZS</productCode><productCodeName>Appliance, Colostomy, Disposable</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Inch" value="5"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Inch" value="5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>