{"publicDeviceRecordKey":"afd2be29-b20e-4a74-98cc-013006611eb9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2024-10-21T00:00:00.000Z","devicePublishDate":"2020-04-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20850017403271","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10850017403274","pkgQuantity":20,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"10850017403274","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"30850017403278","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"20850017403271","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"MASTER CASE"},{"deviceId":"00850017403277","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"EZ FLO","versionModelNumber":"NEZ27100","catalogNumber":"NEZ27100","dunsNumber":"002385425","companyName":"AIR-TITE PRODUCTS COMPANY, INC.","deviceCount":100,"deviceDescription":"HYPODERMIC NEEDLE 27G X 1\"","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"(757) 340-2501","phoneExtension":null,"email":"atinfo@air-tite.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K112057","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59230","gmdnPTName":"Hypodermic needle, single-use","gmdnPTDefinition":"A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FMI","productCodeName":"Needle, Hypodermic, Single Lumen"}]},"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}