{"publicDeviceRecordKey":"cc275aa8-95b8-4e48-ac72-6f779a1d120e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-05-31T00:00:00.000Z","devicePublishDate":"2017-08-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B09030ASP0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B09030ASP1","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B09030ASP0","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Shelf Carton"},{"deviceId":"B09030ASP2","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B09030ASP1","pkgQuantity":9,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Shipper"}]},"brandName":"Control Mechanical Aspirator","versionModelNumber":"30-ASP","catalogNumber":"30-ASP","dunsNumber":"017535668","companyName":"ZIEN MEDICAL TECHNOLOGIES, INC.","deviceCount":1,"deviceDescription":"The Control Mechanical Aspirator is intended to aspirate fluids from the body.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47017","gmdnPTName":"General-purpose syringe, single-use","gmdnPTDefinition":"A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FMF","productCodeName":"Syringe, Piston"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}