{"publicDeviceRecordKey":"111701a8-8c41-4f4b-901c-1ea5edfa407d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2020-05-11T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10850108006551","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00850108006554","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton"},{"deviceId":"00850108006554","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"RespVac™","versionModelNumber":"RTG-03020","catalogNumber":"RTG-03020","dunsNumber":"080216804","companyName":"CUTTING EDGE HC BRANDS LLC","deviceCount":1,"deviceDescription":"RespVac Yankauer Suction Handle Bulb Tip Non-Vented Sterile\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"9999999999","phoneExtension":null,"email":"info@respiratorytg.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35917","gmdnPTName":"Surgical/emergency suction cannula, non-illuminating, single-use","gmdnPTDefinition":"An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JOL","productCodeName":"Catheter And Tip, Suction"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}