{"publicDeviceRecordKey":"0a64f52f-dcba-446e-aa14-3e5c978f63db","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-11-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"CST03424032","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B425CST03424032","pkgQuantity":24,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"B425CST03424032","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Adhesive Disposable SpO2 Sensors with Medaplast Tape - Infant","versionModelNumber":"CST034-2403","catalogNumber":null,"dunsNumber":"134990550","companyName":"MEDIAID INC","deviceCount":1,"deviceDescription":"SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the Oximeter. The sensor contains three optical components, (LED) that serves as light sources and one photodiode that acts as light detector. The optical components are housed in adhesive film/rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated by a connector as specified by the different make/ manufacturer of the pulse Oximeter, with an optional adapter cable for compatible models.","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K041964","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17148","gmdnPTName":"Pulse oximeter, line-powered","gmdnPTDefinition":"A mains electricity (AC-powered) photoelectric device intended for the continuous transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically used bedside.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQA","productCodeName":"Oximeter"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"45"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"95"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"15"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"45"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"5"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"95"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"15"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}