{"publicDeviceRecordKey":"40341dbb-d44c-4742-b499-10d0518b3818","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-06-19T00:00:00.000Z","devicePublishDate":"2015-10-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"50749065191906","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"30749065191902","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"30749065191902","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10749065191908","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"10749065191908","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Parker Flex-Tip","versionModelNumber":"H-PFTVVC-90","catalogNumber":"H-PFTVVC-90","dunsNumber":"022721133","companyName":"SALTER LABS","deviceCount":1,"deviceDescription":"Parker Trach Vac with Flex-Tip and PVC Cuff (H-PFTVVC), 9.0mm                    \n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"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":"303-799-1990","phoneExtension":null,"email":"kmcgregor@parkermedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47691","gmdnPTName":"Cuff-suction endotracheal tube","gmdnPTDefinition":"A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/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":"9.0"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 9.0 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"55"},"storageHandlingLow":{"unit":"Degrees Celsius","value":""},"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,"premarketSubmissions":{"premarketSubmission":[]}}