{"publicDeviceRecordKey":"379c9d80-1eec-42e9-be05-4bade5b7f4f3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-04-26T00:00:00.000Z","devicePublishDate":"2022-06-22T00:00:00.000Z","deviceCommDistributionEndDate":"2023-04-25T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840216119376","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"COLLINS SPORTS","versionModelNumber":"CS3534S","catalogNumber":null,"dunsNumber":"080361159","companyName":"Asp Global, LLC","deviceCount":1,"deviceDescription":"OVERSIZE HOT PAC COVER WITH FOAM, 1/EA\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"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":[]},"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"}]},"productCodes":{"fdaProductCode":[{"productCode":"IMA","productCodeName":"Pack, Heat, Moist"}]},"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":[]}}