{"publicDeviceRecordKey":"332e3cf7-87c8-4916-b082-aaf887f12c8d","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-01-13T00:00:00.000Z","devicePublishDate":"2020-01-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10814105020453","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ACU-EVAC","versionModelNumber":"EVAC II-1","catalogNumber":null,"dunsNumber":"071426803","companyName":"ACUDERM, INC.","deviceCount":1,"deviceDescription":"Top of the line surgical smoke evacuator. Specifically designed for use with erbium smoke.  Also suitable for use with CO2,  hair removal, and other laser  or electrosurgical units in open procedures or with reducer for handpiece or laparoscopic use. 110vac motor\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"954-733-6935","phoneExtension":null,"email":"cust-service@acuderm.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K930043","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37861","gmdnPTName":"Surgical plume evacuation system","gmdnPTDefinition":"A mains electricity (AC-powered) assembly of devices intended to capture smoke generated during open surgical procedures involving tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). It captures the plume (smoke composed of carbonized cell fragments, water vapour, and hydrocarbons from vaporized tissue) near its origin before it becomes dispersed and causes surgical staff respiratory exposure. It consists of a capture tube or wand and four elements to evacuate smoke: user interface, filters, suction source, and exhaust. The system may be mobile (on wheels) and used during closed surgical procedures (e.g., endoscopy, laparoscopy) to clear the view. See also: Gas/fume evacuation system; Anaesthetic gas scavenging unit; Suction system filter, plume particulate; Orthopaedic cement fume evacuator; Surgical plume evacuation system tube","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FYD","productCodeName":"Apparatus, Exhaust, Surgical"}]},"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}