{"publicDeviceRecordKey":"0df4e7a7-5f7c-411e-94f2-2586a5e05657","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":8,"publicVersionDate":"2025-07-31T00:00:00.000Z","devicePublishDate":"2016-09-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10885403274251","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"50885403274259","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10885403274251","pkgQuantity":20,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"}]},"brandName":"BD SmartSite","versionModelNumber":"42521E","catalogNumber":"42521E","dunsNumber":"482631558","companyName":"BD Switzerland Sàrl","deviceCount":1,"deviceDescription":"Gravity Set, Check Valve 3 Needle-Free Valves, 4-Way Stopcock, 2 Ganged Vented/ Nonvented, 346 cm (136 in)","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(844)823-5433","phoneExtension":null,"email":"customer_support@bd.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58977","gmdnPTName":"Basic intravenous administration set, noninvasive","gmdnPTDefinition":"A collection of noninvasive devices intended to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system; some types may in addition be intended for enteral feeding applications. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It neither includes devices intended for invasive use nor a heat exchanger. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FPA","productCodeName":"Set, administration, intravascular"},{"productCode":"LHI","productCodeName":"Set, i.V. Fluid transfer"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size = Priming Volume = 28 millilitre (mL)"},{"sizeType":"Length","size":{"unit":"Inch","value":"136"},"sizeText":null,"sizeString":"Length: 136 Inch"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Fragile, handle with care"},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"125"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":"-40"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Storage Temperature"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}