<?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>e70b5040-68d7-4dfa-89bc-1d4b60faffd8</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-09-05</publicVersionDate><devicePublishDate>2022-08-26</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>00840216106963</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>SARASOTA MEMORIAL</brandName><versionModelNumber>SARASOTA01</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>080361159</dunsNumber><companyName>Asp Global, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>AMENITY KIT, SARASOTA MEM WELCOME, BLUE BAG WITH WHITE LOGO TO INCLUDE 1 DENTAL PACK, 1 FACIAL TISSUE PACK 10CT, 1 PATIENT BEDSIDE PAPER BAG, 1 HAND SANITIZER W/ ALCOHOL, 1 PAIR BLUE EAR PLUGS, AND 1
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>31817</gmdnCode><gmdnPTName>Basic manual toothbrush</gmdnPTName><gmdnPTDefinition>An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EFW</productCode><productCodeName>Toothbrush, Manual</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>