{"publicDeviceRecordKey":"db4fe7bb-57af-4f9b-aeae-79b500b1e013","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2021-10-29T00:00:00.000Z","devicePublishDate":"2020-12-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20888277703640","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10888277703643","pkgQuantity":200,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"10888277703643","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Medline","versionModelNumber":"NON66035","catalogNumber":"NON66035","dunsNumber":"025460908","companyName":"MEDLINE INDUSTRIES, INC.","deviceCount":1,"deviceDescription":"35ML ENFIT SYRINGE, CLEAR","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":"+1(800)633-5463","phoneExtension":null,"email":"service@medline.com"}]},"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":"35"},"sizeText":null,"sizeString":"Total Volume: 35 Milliliter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry. Protect from freezing. Avoid excessive heat."}]},"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":[]}}