{"publicDeviceRecordKey":"5c0e256e-0aac-4e60-bed9-f1699633165d","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-03-12T00:00:00.000Z","devicePublishDate":"2025-03-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00851978007641","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"MicroDoc NPWT System","versionModelNumber":"8463550 4017","catalogNumber":null,"dunsNumber":"079262228","companyName":"Pensar Medical, LLC","deviceCount":1,"deviceDescription":"MicroDoc NPWT Dressing, 10cm x 40cm (5cm x 35cm)","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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K200223","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58202","gmdnPTName":"Negative-pressure wound therapy system, electric, single-use","gmdnPTDefinition":"A portable assembly of devices designed to apply suction to help heal traumatic and chronic skin wounds (e.g., grafts, incisions, burns, ulcers) with low to moderate levels of exudate. It typically consists of an electrically-powered vacuum pump, a highly-absorbent wound dressing and/or collection canister to contain the exudate, and a connection tube. The pump applies continuous or intermittent negative pressure to the wound via the tube/dressing to decompress capillaries/lymphatic vessels, improve blood/interstitial fluid circulation, draw wound edges together, facilitate granulation tissue formation, and prepare the wound bed for closure. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OMP","productCodeName":"Negative Pressure Wound Therapy Powered Suction Pump"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}