{"publicDeviceRecordKey":"87e78e4c-68cd-4ea2-a503-c07b16fa751c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-10-23T00:00:00.000Z","devicePublishDate":"2025-10-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08809108018564","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"28809108018568","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08809108018564","pkgQuantity":48,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton box"}]},"brandName":"Spectra","versionModelNumber":"Spectra breast shield kit(32mm) ","catalogNumber":null,"dunsNumber":"688451947","companyName":"UZINMEDICARE CO.,LTD","deviceCount":1,"deviceDescription":"Spectra breast kit for breast pump including 32mm breast shield set. (excluding bottle set)","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":[]},"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":[]},"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":[]}}