{"publicDeviceRecordKey":"6c8c9620-0042-41b9-90bc-047554f9461b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2026-05-27T00:00:00.000Z","devicePublishDate":"2023-05-02T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"60749836052013","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00749836052011","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"00749836052011","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Bed Buddy ","versionModelNumber":"TPF5201LP","catalogNumber":null,"dunsNumber":"867673159","companyName":"Drive Devilbiss Healthcare","deviceCount":1,"deviceDescription":"6\" x 12\" Hot N' Cold Wrap","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"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":"800-376-7263","phoneExtension":null,"email":"customerservice@compasshealthbrands.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34971","gmdnPTName":"Moist-heat pack","gmdnPTDefinition":"A device intended to be applied with pressure to the body surface to provide moist heat therapy to reduce muscle spasms and cramps and/or joint and muscle stiffness and pain. It usually consists of a soft pad or a small pouch made of cotton, gauze, or linen available in a variety of thickness; it may also contain gel or absorbent materials. The device can be warmed in hot water or in a microwave oven. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"15026","gmdnPTName":"Moist-cold pack","gmdnPTDefinition":"A non-sterile device intended to be temporarily applied to a particular area of the body surface to provide moist cold. It typically consists of a disposable pad/pack/towel that includes an overlapping of several layers of fabric (e.g., gauze, cotton) and is intended to apply moist cold to the tissues after immersion in cold water and freed from excess moisture; it is not a compression bandage. It is typically used for temporary vasoconstriction of superficial blood vessels to help control bleeding, to inhibit inflammation and microbial activity in the early stages of infection, and to prevent/control oedema after strains or contusions. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IME","productCodeName":"Pack, Hot Or Cold, Reusable"}]},"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":[]}}