{"publicDeviceRecordKey":"798333ab-9073-45df-beb0-a23613117ae1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-06-18T00:00:00.000Z","devicePublishDate":"2017-10-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00850836007014","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00850836007052","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007014","pkgQuantity":4000,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00850836007038","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007014","pkgQuantity":1000,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Inner Pack"},{"deviceId":"00850836007045","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007038","pkgQuantity":4,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"00850836007649","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007014","pkgQuantity":24,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Plastic Bag"},{"deviceId":"00850836007656","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007014","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Plastic Bag"},{"deviceId":"00850836007663","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007014","pkgQuantity":100,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Plastic Bag"},{"deviceId":"00850836007670","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850836007014","pkgQuantity":200,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Plastic Bag"}]},"brandName":"L.A.Confidential - Love Triangle","versionModelNumber":"LAC0001LT","catalogNumber":null,"dunsNumber":"177056145","companyName":"CAUTION WEAR CORP","deviceCount":1,"deviceDescription":"Male Latex Condom, Ribbed-Studded-Contoured, Regular Fit (53 mm), Lubricated With Silicon-Based Lubricant, Non-Spermicidal, Single Foil Pocket, Unit of Use.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"603-598-8500","phoneExtension":null,"email":"anatoli@cautionwearcorp.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45138","gmdnPTName":"Basic male condom, Hevea-latex","gmdnPTDefinition":"A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HIS","productCodeName":"Condom"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"100"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"32"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}