{"publicDeviceRecordKey":"c5358b98-f162-4abb-bd65-57405748feef","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-07-29T00:00:00.000Z","devicePublishDate":"2024-07-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840828192552","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SPO2 AD CB,NK 14M,DB9F KEY,2.5M","versionModelNumber":"OCT111-L","catalogNumber":"29128","dunsNumber":"796452311","companyName":"CURBELL MEDICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"SPO2 AD CB,NK 14M,DB9F KEY,2.5M","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-235-7500","phoneExtension":null,"email":"mwinter@curbell.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K222370","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47487","gmdnPTName":"Electrical-only medical device connection cable, reusable","gmdnPTDefinition":"A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DSA","productCodeName":"Cable, Transducer And Electrode, Patient, (Including Connector)"}]},"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}