{"publicDeviceRecordKey":"c3e28721-483d-40d7-984d-733c5a3ac971","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-12-04T00:00:00.000Z","devicePublishDate":"2019-03-05T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00850005738121","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PRIMUS Sterilizer","versionModelNumber":"PSS8-AA-M","catalogNumber":null,"dunsNumber":"825069404","companyName":"Primus Sterilizer Company, LLC","deviceCount":1,"deviceDescription":"Steam Sterilizer, Healthcare, AA","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"402-344-4200","phoneExtension":null,"email":"xxx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K093333","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38671","gmdnPTName":"Steam sterilizer","gmdnPTDefinition":"A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FLE","productCodeName":"Sterilizer, Steam"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}