{"publicDeviceRecordKey":"8808ee2c-9fc5-4f6d-aded-daa3b9e6da61","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-10-12T00:00:00.000Z","devicePublishDate":"2022-12-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04042809020199","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04042809020175","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"04042809020175","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Cover-Roll®","versionModelNumber":"45548-00","catalogNumber":"45548-00","dunsNumber":"342651662","companyName":"BSN medical GmbH","deviceCount":1,"deviceDescription":"COVERROLL STRETCH 10CMX1.84M WHITE 1","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"+1(800)537-1063","phoneExtension":null,"email":"HMS.ORDERS@ESSITY.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16866","gmdnPTName":"Dressing-fixation skin adhesive tape, non-silicone","gmdnPTDefinition":"A long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KGX","productCodeName":"Tape and bandage, adhesive"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"184"},"sizeText":null,"sizeString":"Length: 184 Centimeter"},{"sizeType":"Width","size":{"unit":"Centimeter","value":"10"},"sizeText":null,"sizeString":"Width: 10 Centimeter"}]},"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":[]}}