{"publicDeviceRecordKey":"cdcdcd21-bd05-4d36-9a13-22fa14751c13","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-12-19T00:00:00.000Z","devicePublishDate":"2022-12-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07640142190882","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"EasyOne Filter SP","versionModelNumber":"2091-412","catalogNumber":null,"dunsNumber":"487451916","companyName":"NDD Medizintechnik AG","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K221250","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61097","gmdnPTName":"Pulmonary function testing filter/mouthpiece","gmdnPTDefinition":"A non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CAH","productCodeName":"Filter, Bacterial, Breathing-Circuit"}]},"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}