{"publicDeviceRecordKey":"670c6121-3c9b-4f4b-8da9-656fb5167394","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-05-26T00:00:00.000Z","devicePublishDate":"2023-05-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B708XCPRP300","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B708XCPRP301","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B708XCPRP300","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case "}]},"brandName":"XCELL","versionModelNumber":"XC-PRP-30","catalogNumber":null,"dunsNumber":"079560357","companyName":"APEX BIOLOGIX , LLC","deviceCount":1,"deviceDescription":"XCELL Platelet Concentrating System 30ml XC-PRP-30 ","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"844-897-4910","phoneExtension":null,"email":"orders@apexbiologix.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46923","gmdnPTName":"Haematological concentrate system preparation kit, platelet concentration","gmdnPTDefinition":"A collection of devices designed to prepare platelet-rich plasma (PRP) or platelet-rich fibrin matrix (PRFM) from an autologous blood specimen for application to soft-tissue wounds and injured bone to accelerate healing and/or achieve haemostasis. It includes single- or double- (concentric) barrel syringe(s) with connecting tubes and caps. Blood is collected by venous puncture and processed in a centrifuge, increasing the concentration of platelets within the plasma or fibrin matrix; this may be done at the point-of-care. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ORG","productCodeName":"Platelet And Plasma Separator For Bone Graft Handling"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}