{"publicDeviceRecordKey":"7e325f8e-83f3-4b71-be3c-06ca16f3b1b5","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-10-23T00:00:00.000Z","devicePublishDate":"2019-03-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04035873061014","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04035873061007","pkgQuantity":40,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CARTON"},{"deviceId":"04035873061007","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"04035873060994","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"HSW HENKE-JECT®","versionModelNumber":"8300022134","catalogNumber":"8300022134","dunsNumber":"317326411","companyName":"Henke-Sass, Wolf GmbH","deviceCount":100,"deviceDescription":"HSW HENKE-JECT® 27G x 1 1/4 -  0,40 x 30 MM\n","DMExempt":true,"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":[]},"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":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"30"},"sizeText":null,"sizeString":"Length: 30 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"0.40"},"sizeText":null,"sizeString":"Outer Diameter: 0.40 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Protect from sunlight, keep dry"}]},"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":[]}}