{"publicDeviceRecordKey":"42192015-4d45-4c4a-9e51-206c3478ffb0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-02-09T00:00:00.000Z","devicePublishDate":"2022-02-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00850023375018","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CardiaMend","versionModelNumber":"CMUS-10NS-0816","catalogNumber":"CMUS-10NS-0816","dunsNumber":"117912350","companyName":"Helios Cardio Inc.","deviceCount":1,"deviceDescription":"CardiaMend 1.0 Pericardial and Epicardial Reconstruction Matrix 8 x 16 cm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-339-707-7788","phoneExtension":null,"email":"support@helioscardio.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K210331","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35273","gmdnPTName":"Cardiovascular patch, animal-derived","gmdnPTDefinition":"An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PSQ","productCodeName":"Intracardiac Patch Or Pledget, Biologically Derived"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"8"},"sizeText":null,"sizeString":"Length: 8 Centimeter"},{"sizeType":"Width","size":{"unit":"Centimeter","value":"16"},"sizeText":null,"sizeString":"Width: 16 Centimeter"},{"sizeType":"Height","size":{"unit":"Millimeter","value":"1"},"sizeText":null,"sizeString":"Height: 1 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"15"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep Away from Excessive Heat"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}