{"publicDeviceRecordKey":"f6b78f52-8411-44a2-b8bb-e416d77884a4","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-11-20T00:00:00.000Z","devicePublishDate":"2023-11-10T00:00:00.000Z","deviceCommDistributionEndDate":"2023-11-15T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"06975983272048","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Momcozy","versionModelNumber":"MCBOC01_40PC","catalogNumber":null,"dunsNumber":"615691114","companyName":"Shenzhen Lutejiacheng Supply Chain Management Co., Ltd.","deviceCount":1,"deviceDescription":"Baby Oral Cleaner","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"48037","gmdnPTName":"Oral care swab","gmdnPTDefinition":"A device designed as a piece of non-treated, absorbent material on a wooden, paper, or plastic stick and intended to moisten and clean a patient's oral cavity to maintain normal mouth patency and hygiene. It is commonly used on intensive care and long-term care patients to administer moisture, mouthwash, or medications to improve the physical condition of the oral cavity and possibly help reduce the incidence of patient infection. It is typically applied to the patient by nursing staff in hospitals and institutions, or attendants in homecare settings. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KXF","productCodeName":"Applicator, Absorbent Tipped, Non-Sterile"}]},"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":[]}}