{"publicDeviceRecordKey":"e9000fbf-20e0-4b81-a87f-6602876b0d50","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-02-05T00:00:00.000Z","devicePublishDate":"2014-07-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"06221139123796","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Amecath dual lumen catheter","versionModelNumber":"PDLC-15.531-K","catalogNumber":null,"dunsNumber":"565404779","companyName":"Ameco Medical Industries","deviceCount":1,"deviceDescription":"Permthane Long term dual lumen catheter kit size 15.5 Fr tip to cuff length 31 Cm total length 36 Cm","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"2038804091","phoneExtension":null,"email":"ray.k@arazygroup.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K131814","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37278","gmdnPTName":"Double-lumen haemodialysis catheter, implantable","gmdnPTDefinition":"An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (\u003e 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MSD","productCodeName":"Catheter, Hemodialysis, Implanted"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"15.5"},"sizeText":null,"sizeString":"Catheter Gauge: 15.5 French"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"31"},"sizeText":null,"sizeString":"Length: 31 Centimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}