{"publicDeviceRecordKey":"7debe283-9446-4c45-8363-a2c7b8701196","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-07-17T00:00:00.000Z","devicePublishDate":"2025-07-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04719873698226","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"S1001-8240","catalogNumber":null,"dunsNumber":"658863238","companyName":"CARILEX MEDICAL, INC.","deviceCount":1,"deviceDescription":"VT•100/VT•200 Carrying Bag for 1000ml Canister Carilex-1p","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47408","gmdnPTName":"Negative-pressure wound therapy system pump, electric","gmdnPTDefinition":"A mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OMP","productCodeName":"Negative Pressure Wound Therapy Powered Suction Pump"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}