{"publicDeviceRecordKey":"0f862dfd-f465-40f7-9185-21882473f428","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2019-05-23T00:00:00.000Z","devicePublishDate":"2019-02-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00856571007258","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Archimedes Access Key, 10-pack","versionModelNumber":"10009-2","catalogNumber":"10009-2","dunsNumber":"078684808","companyName":"BRONCUS MEDICAL INC.","deviceCount":1,"deviceDescription":"Archimedes Planning Software is software installed on a laptop computer used for planning bronchoscopic procedures. The Planning program provides a planning system to select the region of interest and preview virtual paths to the region of interest through both airways and lung tissue.","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":[{"phone":"650-428-1600","phoneExtension":null,"email":"CustomerSupport@Broncus.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58042","gmdnPTName":"Virtual bronchoscopic navigation PACS software","gmdnPTDefinition":"A software application intended to add specific image processing and/or analysis capabilities to a picture archiving and communication system (PACS) used for virtual bronchoscopic navigation (VBN). It is typically used by a bronchoscopist as a navigation system to help plan and provide guidance of a flexible bronchoscope to predefined target sites [also referred to as region of interest (ROI)] in the lung tissue of the tracheobronchial tree. It typically uses computed tomography (CT) scans in digital imaging and communications in medicine (DICOM) format. This software is typically installed in an off-the-shelf desktop or laptop computer.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LLZ","productCodeName":"System, Image Processing, Radiological"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Room Temperature"}]},"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":[]}}