{"publicDeviceRecordKey":"ffbf8587-85b5-427b-8450-d299337767f7","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-08-07T00:00:00.000Z","devicePublishDate":"2019-07-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M752HCT1CCLL5","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M752HCT1CCLL1","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"outer box"},{"deviceId":"M752HCT1CCLL0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M752HCT1CCLL1","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"M752HCT1CCLL0","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Inner package"}]},"brandName":"Stradis Medical, LLC","versionModelNumber":"HCT1CC-LL","catalogNumber":null,"dunsNumber":"043537671","companyName":"STRADIS MEDICAL LLC","deviceCount":1,"deviceDescription":"1CC LUER LOCK SYRINGES","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-424-8520","phoneExtension":null,"email":"CS@stradishealthcare.com"}]},"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":[]},"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":[]}}