{"publicDeviceRecordKey":"7ae4240a-cef4-4783-91df-a45ceabac990","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-07-13T00:00:00.000Z","devicePublishDate":"2019-03-21T00:00:00.000Z","deviceCommDistributionEndDate":"2023-07-12T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"R88901","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NES Reprocessed Visions PV .035 Digital IVUS Catheter","versionModelNumber":"R-88901","catalogNumber":"R-88901","dunsNumber":"608625823","companyName":"NORTH EAST SCIENTIFIC INC","deviceCount":1,"deviceDescription":"The device is the Philips Vision PV .035 Digital IVUS catheter that is reprocessed by Northeast Scientific, Inc. (NES).","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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"203-756-2111","phoneExtension":null,"email":"info@smarthealth-care.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K181126","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64174","gmdnPTName":"Intravascular ultrasound imaging catheter, reprocessed","gmdnPTDefinition":"A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OWQ","productCodeName":"Reprocessed Intravascular Ultrasound Catheter"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Working Length","size":{"unit":"Centimeter","value":"90"},"sizeText":null,"sizeString":"Catheter Working Length: 90 Centimeter"},{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Inch","value":".035"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: .035 Inch"}]},"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}