{"publicDeviceRecordKey":"89a69dcf-7783-491f-aaff-be789900c89d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-05-20T00:00:00.000Z","devicePublishDate":"2020-01-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10884521761865","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"20884521761862","pkgQuantity":100,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"20884521761862","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Microstream Advance","versionModelNumber":"MVANOL100U","catalogNumber":null,"dunsNumber":"600111512","companyName":"ORIDION MEDICAL 1987 LTD.","deviceCount":1,"deviceDescription":"Adult Nasal CO2 Filter Line with O2 Tubing; Short-term use: Procedural/Emergency","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(508)261-8000","phoneExtension":null,"email":"covidien.udi@covidien.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36306","gmdnPTName":"Nasal oxygen cannula, carbon-dioxide-sampling","gmdnPTDefinition":"A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs. It is available in one-, two-, or four-prong configurations. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CCK","productCodeName":"ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Airflow Volume, less than or equal to 5, Liter/min;"},{"sizeType":"Length","size":{"unit":"Meter","value":"4"},"sizeText":null,"sizeString":"Length: 4 Meter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"90"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"131"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"-4"},"storageHandlingSpecialConditionText":null}]},"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":[]}}