{"publicDeviceRecordKey":"ffc369ae-51fb-4a97-9c42-25fb22ce11ba","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-06-19T00:00:00.000Z","devicePublishDate":"2019-11-11T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EMIP50101010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Wireless Pulse Oximetry Sensor for Tesla DUO","versionModelNumber":"Wireless Pulse Oximetry Sensor for Tesla DUO","catalogNumber":"5010101","dunsNumber":"324416379","companyName":"MIPM Mammendorfer Institut für Physik und Medizin GmbH","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+49814592090","phoneExtension":null,"email":"info@mipm.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K153739","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36554","gmdnPTName":"Patient monitoring system module, pulse oximetry","gmdnPTDefinition":"A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MWI","productCodeName":"Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)"}]},"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}