{"publicDeviceRecordKey":"83d9b3c5-76fd-4202-a6c6-e2a4efb132ab","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2018-09-12T00:00:00.000Z","devicePublishDate":"2017-04-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18050616611557","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08050616611550","pkgQuantity":60,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"box"},{"deviceId":"08050616611550","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"crn CRONO Syringe reservoir","versionModelNumber":"CRN50ML","catalogNumber":null,"dunsNumber":"438017964","companyName":"CANE' SPA","deviceCount":1,"deviceDescription":"50 ml reservoir for CRONO ambulatory syringe infusion pumps","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"(630) 845-7867","phoneExtension":null,"email":"rmcdowell@intrapump.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K041414","supplementNumber":"000"}]},"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":"FRN","productCodeName":"Pump, Infusion"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"50"},"sizeText":null,"sizeString":"Total Volume: 50 Milliliter"}]},"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}