{"publicDeviceRecordKey":"9ad842ce-ffd7-402d-85da-db1006f36fe6","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-12-16T00:00:00.000Z","devicePublishDate":"2022-12-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20787551014796","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00787551014792","pkgQuantity":100,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"00787551014792","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CL20674 Custom Med Label Pack","versionModelNumber":"CL20674","catalogNumber":"CL20674","dunsNumber":"868042664","companyName":"XODUS MEDICAL, INC.","deviceCount":1,"deviceDescription":"CL20674 Custom Med Label Pack","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(724)337-5500","phoneExtension":null,"email":"plloyd@xodusmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47731","gmdnPTName":"Procedural medication labelling set","gmdnPTDefinition":"A collection of devices intended to provide clinical staff with a standardized method to label medications, medication containers (e.g., syringes, medicine cups, basins), or other solutions in and outside of the sterile field in perioperative and other procedural settings. It typically includes a permanent marking pen and various labels typically made of moisture resistant plastic material and provided with standard medication/drug/solution text (e.g., lidocaine, heparin, morphine sulfate, saline, sterile water) which can be further qualified using the pen; the labels may also include additional text fields (e.g., for date, initials). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LYV","productCodeName":"LABEL OR TAG, STERILE"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Radiation Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}