{"publicDeviceRecordKey":"f0de7587-b282-4327-aa7a-61deb06182ee","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2020-06-19T00:00:00.000Z","devicePublishDate":"2016-06-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00182151000556","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"10182151000553","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00182151000556","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"inner carton"}]},"brandName":"EndoFlex","versionModelNumber":"Oral/Nasal 121080","catalogNumber":"121080","dunsNumber":"606864184","companyName":"MERLYN ASSOCIATES, INC.","deviceCount":1,"deviceDescription":"8.0mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaque line and smooth Murphy tip\n","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":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K031794","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46967","gmdnPTName":"Basic endotracheal tube, single-use","gmdnPTDefinition":"A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BTR","productCodeName":"Tube, Tracheal (W/Wo Connector)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"8.0"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 8.0 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"120"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","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}