{"publicDeviceRecordKey":"ec3c76d0-ea94-42ca-9dca-a0bf42692870","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-11-03T00:00:00.000Z","devicePublishDate":"2019-02-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10021292012806","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00021292012809","pkgQuantity":30,"pkgDiscontinueDate":"2025-08-15","pkgStatus":"Not in Commercial Distribution","pkgType":"CASE"},{"deviceId":"00021292012809","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00021292012939","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TRUEplus","versionModelNumber":"TRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct box","catalogNumber":"S5H01D31-100TC","dunsNumber":"151810868","companyName":"TRIVIDIA HEALTH, INC.","deviceCount":100,"deviceDescription":"TRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct box","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":true,"contacts":{"customerContact":[{"phone":"+1(800)803-6025","phoneExtension":null,"email":"customercare@trividiahealth.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K180720","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44127","gmdnPTName":"Autoinjector needle","gmdnPTDefinition":"A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FMI","productCodeName":"Needle, Hypodermic, Single Lumen"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"0.3125"},"sizeText":null,"sizeString":"Length: 0.3125 Inch"},{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"31"},"sizeText":null,"sizeString":"Needle Gauge: 31 Gauge"}]},"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}