{"publicDeviceRecordKey":"38503736-d7bc-42b9-a3e3-13c79a37b2b9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-10-07T00:00:00.000Z","devicePublishDate":"2018-01-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00851908007123","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"FaceLake","versionModelNumber":"FL-420","catalogNumber":null,"dunsNumber":"029578633","companyName":"LORTE TECHNOLOGIES, INC","deviceCount":1,"deviceDescription":"The Facelake FL-420 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"1-847-234-0754","phoneExtension":null,"email":"info@pulseoximeter.org"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K082641","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45607","gmdnPTName":"Pulse oximeter","gmdnPTDefinition":"An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQA","productCodeName":"Oximeter"}]},"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}