{"publicDeviceRecordKey":"b2721a98-1ce2-4e30-8d50-8fc5387c1ddd","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-06-13T00:00:00.000Z","devicePublishDate":"2023-06-05T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10850801006704","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850801006707","pkgQuantity":500,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Inner Pack"},{"deviceId":"00850801006707","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"20850801006701","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10850801006704","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"}]},"brandName":"Vesco Medical 5mL ENFit Tip Syringe","versionModelNumber":"VED-605B","catalogNumber":null,"dunsNumber":"119007223","companyName":"Vesco Medical, LLC","deviceCount":1,"deviceDescription":"5mL ENFit Tip Syringe Pharmacy Bulk Pack","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"6149145991","phoneExtension":null,"email":"info@vescomedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K190502","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59040","gmdnPTName":"ENFit oral/enteral syringe, single-use","gmdnPTDefinition":"A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"PNR","productCodeName":"Enteral Syringes With Enteral Specific Connectors"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"5"},"sizeText":null,"sizeString":"Total Volume: 5 Milliliter"}]},"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}