{"publicDeviceRecordKey":"4810ba76-9200-458e-9d1b-f63abe18b9f8","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-06-12T00:00:00.000Z","devicePublishDate":"2020-06-04T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817012024944","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"K-3oem EZ-ZONE","versionModelNumber":"K-3oem-EU-MS-8","catalogNumber":"K-3oem-EU-MS-8","dunsNumber":"135241342","companyName":"KAP MEDICAL","deviceCount":1,"deviceDescription":"Pulsation, True Low Air Loss 8\" High Mattress, Standard EU System\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":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"951-340-4360","phoneExtension":null,"email":"sales@kapmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17593","gmdnPTName":"Low-air-loss bed","gmdnPTDefinition":"A mains electricity (AC-powered) bed that permits a controlled release of air through its dedicated mattress and is used for tissue pressure management during patient confinement in a hospital acute care department and nursing homes. The device consists of a mattress made of a series of connected air inflated pillows upon which the patient lies, a compressor with a feed system, filters and a built-in control unit.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IOQ","productCodeName":"Bed, Flotation Therapy, 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":[]}}