{"publicDeviceRecordKey":"70a54422-c2c6-42b7-8bcd-3566d33fc2c8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-08-14T00:00:00.000Z","devicePublishDate":"2022-06-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B929N4N2600MP4MP40","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Western/Scott Fetzer","versionModelNumber":"N4N2-600MP4MP4","catalogNumber":"N4N2-600MP4MP4","dunsNumber":"148634731","companyName":"Western Enterprises","deviceCount":1,"deviceDescription":"PKGD:  N4-N2O-600-MP4-MP4\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-783-7890","phoneExtension":null,"email":"SALES@WESTERNENTERPRISES.COM"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37936","gmdnPTName":"Nitrous oxide low pressure hose","gmdnPTDefinition":"A length of reinforced colour-coded flexible tubing produced according to ISO5359 intended to conduct compressed nitrous oxide (N2O) from an N2O terminal unit or N2O cylinder to a medical device that functions with N2O (e.g., ventilator, anaesthesia unit, analgesia unit, or other N2O dependent medical device). The gas pressure in the tubing will be low, a \"working pressure\" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BYX","productCodeName":"Tubing, Pressure And Accessories"}]},"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":[]}}