{"publicDeviceRecordKey":"86d4853a-d05a-4bb1-93ae-ed1731d9ed26","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-09-20T00:00:00.000Z","devicePublishDate":"2024-09-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"28809108017448","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08809108017444","pkgQuantity":48,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton box"},{"deviceId":"08809108017444","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Spectra","versionModelNumber":"Spectra accessory(16mm Breast shield) ","catalogNumber":"MM012716","dunsNumber":"688451947","companyName":"UZINMEDICARE CO.,LTD","deviceCount":1,"deviceDescription":"Spectra accessory set for breast pump including 16mm breast shield set(excluded bottle set).\nBreast shield is a funnel shaped accessory, which come in contact with breast to express milk. \nIt is connected to backdraft prevention unit(cap), pressure adjustment unit(silicon head) and bottle when used.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"+821053081195","phoneExtension":null,"email":"shahn@uzinmedical.co.kr"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61734","gmdnPTName":"Breast pump support kit, reusable","gmdnPTDefinition":"A collection of items intended to be used in conjunction with a manual or electric breast pump (not included) to assist mothers in extracting milk from the breast for collection and/or feeding an infant. It typically includes various items such as funnel-like breast shields, tubing, connectors, and infant feeding bottle. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HGX","productCodeName":"Pump, Breast, Powered"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"24"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 24 Millimeter"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}