{"publicDeviceRecordKey":"c7e2b141-29e0-4a59-8636-825eae9c2846","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-09-28T00:00:00.000Z","devicePublishDate":"2016-09-20T00:00:00.000Z","deviceCommDistributionEndDate":"2021-09-23T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"H787600000015","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"H787600000010","pkgQuantity":5,"pkgDiscontinueDate":"2021-09-23","pkgStatus":"Not in Commercial Distribution","pkgType":"BOX"},{"deviceId":"H787600000010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AquaLiner","versionModelNumber":"60000001","catalogNumber":null,"dunsNumber":"079105071","companyName":"ANGIODYNAMICS, INC.","deviceCount":1,"deviceDescription":"AquaLiner Hydrophilic Ni-Ti Alloy Guidewire, 3cm Straight Stiff Tip","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":"+1(518)795-1676","phoneExtension":null,"email":"dgreer@angiodynamics.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35094","gmdnPTName":"Cardiac/peripheral vascular guidewire, single-use","gmdnPTDefinition":"A long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQX","productCodeName":"WIRE, GUIDE, CATHETER"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Inch","value":"0.035"},"sizeText":null,"sizeString":"Outer Diameter: 0.035 Inch"},{"sizeType":"Length","size":{"unit":"Centimeter","value":"150"},"sizeText":null,"sizeString":"Length: 150 Centimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"27"},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":null}]},"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":[]}}