{"publicDeviceRecordKey":"5413324a-9b3e-4cb1-96e1-708582b76bbd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-01-05T00:00:00.000Z","devicePublishDate":"2021-01-01T00:00:00.000Z","deviceCommDistributionEndDate":"2023-01-04T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"40677964020832","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"40677964020825","pkgQuantity":10,"pkgDiscontinueDate":"2023-01-04","pkgStatus":"Not in Commercial Distribution","pkgType":"Case"},{"deviceId":"40677964020825","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Custom Procedure Kit","versionModelNumber":"4002972","catalogNumber":null,"dunsNumber":"068199363","companyName":"MEDIVATORS INC.","deviceCount":1,"deviceDescription":"Endo Carry-On Procedure Kit","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)444-4729","phoneExtension":null,"email":"custserv@MEDIVATORS.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61950","gmdnPTName":"Endoscopy preparation kit","gmdnPTDefinition":"A collection of various devices intended to be used in the preparation of a patient and equipment for an endoscopy procedure of the gastrointestinal tract or airways. It includes devices intended to support the procedure (e.g., bite block, lubricant jelly, transport pad, bowl, cleaning devices); it does not contain pharmaceuticals. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MNL","productCodeName":"Accessories, Cleaning Brushes, For Endoscope"}]},"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":[]}}