{"publicDeviceRecordKey":"7837b1a7-c2ee-4800-ac1b-2ce2ad04d60c","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-09-19T00:00:00.000Z","devicePublishDate":"2022-09-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00670482000609","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"10670482000606","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00670482000609","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null}]},"brandName":"ook snow MH","versionModelNumber":"FL36 ook snow MH","catalogNumber":"FL36","dunsNumber":"249675476","companyName":"Umano Medical Inc","deviceCount":1,"deviceDescription":"The ook snow MH, model FL36, is an AC-powered medical bed with 4 built-in electric DC actuators and controls that is intended for medical purposes in mental health care units and/or environments. The maximum safe working load of the bed is of 600lb.\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34870","gmdnPTName":"Basic electric hospital bed","gmdnPTDefinition":"A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FNL","productCodeName":"Bed, Ac-Powered Adjustable Hospital"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"95"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"5"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"104"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"50"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"100"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"158"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"-40"},"storageHandlingSpecialConditionText":null}]},"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":[]}}