{"publicDeviceRecordKey":"bc6c9b60-e0cf-488e-b227-6030589d7a48","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-01-15T00:00:00.000Z","devicePublishDate":"2026-01-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"16972798250053","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"06972798250056","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"06972798250056","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Youha","versionModelNumber":"THE ONE","catalogNumber":null,"dunsNumber":"412923842","companyName":"Ningbo Youhe Mother And Baby Products Co., Ltd.","deviceCount":1,"deviceDescription":"The Youha, Bebebao, and Yiyadodo electric breast pumps are single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. THE ONE, YH-8012, BB-5020 and YY-5030 have both single (pumping from one breast) and double pumping (pumping from both breasts)\nconfigurations. YY-8011 and YH-8019 have a single pumping configuration only.A reciprocating diaphragm vacuum pump, driven by a microprocessor, generates the suction to extract the milk at vacuum levels up to 280 mmHg. The user interface for the THE ONE, YH-8012, BB-5020 and YY-5030 models consists of a front panel\nkeypad and LCD display or LED display in which the user switches between modes and controls the vacuum pressure. The YY-5030 model does not have any visual indicators on the pump housing","DMExempt":false,"premarketExempt":false,"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":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K203148","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38478","gmdnPTName":"Breast pump, electric","gmdnPTDefinition":"A mains electricity (AC-powered) device used to extract milk from the breast, typically for collecting and feeding to an infant. The device produces a continuous low-grade suction through a funnel-like component that is applied to the breast; the milk collects in an attached vessel (e.g., a sterilized bottle). The device may have a safety mechanism to prevent a potentially harmful increase in negative pressure.","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}