{"publicDeviceRecordKey":"da1ae8ad-6d9e-4542-b70b-7241d7576ac9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-03-12T00:00:00.000Z","devicePublishDate":"2016-09-13T00:00:00.000Z","deviceCommDistributionEndDate":"2024-03-08T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"H787107071045","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"H787107071040","pkgQuantity":10,"pkgDiscontinueDate":"2024-03-08","pkgStatus":"Not in Commercial Distribution","pkgType":"BOX"},{"deviceId":"H787107071040","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Soft-Vu","versionModelNumber":"10707104","catalogNumber":null,"dunsNumber":"079105071","companyName":"ANGIODYNAMICS, INC.","deviceCount":1,"deviceDescription":"Soft-Vu Angiographic Catheter, Pigtail, Non-Braided","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":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"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K112452","supplementNumber":"000"},{"submissionNumber":"K161596","supplementNumber":"000"},{"submissionNumber":"K173762","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"10688","gmdnPTName":"Angiographic catheter, single-use","gmdnPTDefinition":"A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DQO","productCodeName":"CATHETER, INTRAVASCULAR, DIAGNOSTIC"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"110"},"sizeText":null,"sizeString":"Length: 110 Centimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"1.4"},"sizeText":null,"sizeString":"Outer Diameter: 1.4 Millimeter"},{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"4"},"sizeText":null,"sizeString":"Catheter Gauge: 4 French"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"27"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}