{"publicDeviceRecordKey":"fd696211-d45d-42fe-b8f8-8adc1e3b8b1f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2018-11-16T00:00:00.000Z","devicePublishDate":"2016-08-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"30680651136818","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10680651136814","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CS"},{"deviceId":"10680651136814","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Halyard","versionModelNumber":"13681","catalogNumber":"P100X2-14","dunsNumber":"079375431","companyName":"Avanos Medical, Inc.","deviceCount":1,"deviceDescription":"SURGPN,100X2-14,PMPSAF,-,OQ,5","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"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":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1(844)425-9273","phoneExtension":null,"email":"xxx@xxx.xxx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K063530","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46542","gmdnPTName":"Elastomeric infusion pump system","gmdnPTDefinition":"An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MEB","productCodeName":"PUMP, INFUSION, ELASTOMERIC"}]},"deviceSizes":{"deviceSize":[]},"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}