{"publicDeviceRecordKey":"f64b4325-276c-4b24-a295-d6cec5b37927","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-07-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B286FHCDWC36TLGD220MB1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DUAL CHAMBER BLANKET/FLUID WARMER, GLASS DOOR, MOBILE BASE","versionModelNumber":"FHCDWC36-TL-G-D-220-MB","catalogNumber":"FHCDWC36-TL-G-D-220-MB","dunsNumber":"188660844","companyName":"M.A.C. MEDICAL INC.","deviceCount":1,"deviceDescription":"Overall size 30”W x 26.5”D x 74.5”T.  \n17.59 Cubic ft. storage\n4 Adjustable shelves.  \nUpper Chamber I.D. 26”W x 23”D x 25”T  \n8.63 Cubic ft. storage.\nTemperature Range: 90-160 F\nAccuracy +/- 2 degrees F \nLower chamber I.D. 26 “W x 23”D x 26”T  \n8.96 Cubic ft. storage. \nTemperature Range: 90-160 F \nAccuracy +/- 2 degrees F  \nKeyed temperature lock\nGlass doors.  \nAudible and visual over-temp alarm.  \nDigital control\nMobile Base\nElectrical:  \n220V, 6 Amp, 60 Hz.  \n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"(877) 828-9975","phoneExtension":null,"email":"info@macmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K080609","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"55829","gmdnPTName":"Blanket warming cabinet, dry-heat","gmdnPTDefinition":"A mains electricity (AC-powered) device designed to warm blankets with hot dry air. It is typically a high capacity (e.g., 0.2 to 0.5 m3) unit with appropriate perforated shelves for blanket positioning, avoiding contact with very hot surfaces to prevent scorching. Hot dry air is usually circulated to heat blankets in a temperature range from 30 to 90? C (90 to 200? F).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LHC","productCodeName":"Warmer, Irrigation Solution"}]},"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}