[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NZU":3},{"classification":4,"mappedDevices":79,"similarCandidates":80,"relatedClassifications":163,"syncDates":215},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":15,"raw":16,"created_at":73,"updated_at":74,"recall_count":75,"latest_recall_date":76,"k510_count":75,"pma_count":77,"event_count":78},5136,"NZU","Collector, Urine, Powered, Non Indwelling Catheter","1","876.5250","GU","Gastroenterology, Urology","4","For the non-invasive, non-sterile collection of urine and for patients unable to void on their own or have control of voiding.  Often patient confined to the bed or a wheelchair.",false,true,{"openfda":17,"definition":13,"device_name":7,"review_code":21,"device_class":8,"implant_flag":70,"product_code":6,"review_panel":10,"gmp_exempt_flag":71,"third_party_flag":70,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":70,"medical_specialty_description":11,"summary_malfunction_reporting":72},{"k_number":18,"fei_number":20,"registration_number":64},[19],"K062061",[21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"","3013484413","3016734231","3011802696","3012944064","3009656988","3003102569","1220351","3030394731","3004527595","3011020307","3011533719","3019502344","3013524793","1417592","3005105203","3014498861","3010580321","3002806591","3022121576","3011120183","3039443708","3003755374","3014615175","3012421607","1419181","3003719498","3001436772","3038139564","1018233","3013557562","3013041594","1000237915","3043729119","3032798406","3040278138","3023230882","3040388410","2518417","3009425497","3014437893","3010193531","3009632672",[21,22,23,24,25,65,26,28,66,30,29,31,32,33,34,35,36,37,38,67,40,41,42,43,44,68,45,69,46,49,50,51,52,54,55,56,57,58,59,60,61,62,63],"9614977","9616067","9611590","2087033","8040607","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-19T02:30:42.714273+00:00",1,"2023-11-29",0,3761,[],[81,90,98,106,115,123,131,139,147,155],{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},1985,"泌尿器用カテーテル挿入・採尿キット","Ⅱ","14292000",0.287671,0.282486,0.736495,0.031545,{"medical_device_id":91,"generic_name":92,"class_classification":84,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},2023,"非中心循環系血管内カテーテル","40601000",0.222222,0.197802,0.745889,0.028373,{"medical_device_id":99,"generic_name":100,"class_classification":84,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},1991,"間欠泌尿器用カテーテル","36125000",0.19697,0.281768,0.753715,0.027365,{"medical_device_id":107,"generic_name":108,"class_classification":109,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},432,"緊急時ブラッドアクセス留置用カテーテル","Ⅲ","70320100",0.285714,0.157534,0.701872,0.0268789,{"medical_device_id":116,"generic_name":117,"class_classification":84,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":122},2043,"非中心循環系閉塞術用血管内カテーテル","32584002",0.225,0.15,0.722775,0.0258938,{"medical_device_id":124,"generic_name":125,"class_classification":84,"jmdn_code":126,"name_similarity":127,"definition_similarity":128,"vector_similarity":129,"score":130},2297,"吸引用子宮カテーテル","32655000",0.245614,0.133891,0.703202,0.0254183,{"medical_device_id":132,"generic_name":133,"class_classification":84,"jmdn_code":134,"name_similarity":135,"definition_similarity":136,"vector_similarity":137,"score":138},2063,"滅菌済み体内留置排液用チューブ及びカテーテル","70306000",0.243902,0.134078,0.704724,0.0253815,{"medical_device_id":140,"generic_name":141,"class_classification":84,"jmdn_code":142,"name_similarity":143,"definition_similarity":144,"vector_similarity":145,"score":146},2083,"尿管カテーテル用アダプタ","31973000",0.224138,0.131868,0.701556,0.0232684,{"medical_device_id":148,"generic_name":149,"class_classification":109,"jmdn_code":150,"name_similarity":151,"definition_similarity":152,"vector_similarity":153,"score":154},379,"抗菌泌尿器用カテーテル","34096000",0.15942,0.2,0.766272,0.0163934,{"medical_device_id":156,"generic_name":157,"class_classification":109,"jmdn_code":158,"name_similarity":159,"definition_similarity":160,"vector_similarity":161,"score":162},431,"ウロキナーゼ使用緊急時ブラッドアクセス留置用カテーテル","70320400",0.292683,0.159664,0.684118,0.016129,[164,169,173,177,181,185,189,193,196,200,203,206,209,212],{"product_code":165,"device_name":166,"device_class":167,"k510_count":168},"KNX","Collector, Urine, (And Accessories) For Indwelling Catheter","2",206,{"product_code":170,"device_name":171,"device_class":8,"k510_count":172},"EXJ","Device, Incontinence, Urosheath Type, Sterile",22,{"product_code":174,"device_name":175,"device_class":8,"k510_count":176},"FAQ","Bag, Urine Collection, Leg, For External Use, Sterile",18,{"product_code":178,"device_name":179,"device_class":8,"k510_count":180},"EYZ","System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile",14,{"product_code":182,"device_name":183,"device_class":167,"k510_count":184},"FCN","Urinary Drainage Collection Kit, For Indwelling Catheter",10,{"product_code":186,"device_name":187,"device_class":8,"k510_count":188},"EXI","Device, Paste-On For Incontinence, Sterile",7,{"product_code":190,"device_name":191,"device_class":8,"k510_count":192},"EYT","Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile",4,{"product_code":194,"device_name":195,"device_class":167,"k510_count":192},"FOC","Bag, Urine Collection, Newborn",{"product_code":197,"device_name":198,"device_class":167,"k510_count":199},"FFH","Collector, Urine, Pediatric, For Indwelling Catheter",3,{"product_code":201,"device_name":202,"device_class":8,"k510_count":77},"NNW","Bag, Urine Collection, Leg, For External Use, Non-Sterile",{"product_code":204,"device_name":205,"device_class":8,"k510_count":77},"NNX","Device, Incontinence, Urosheath Type, Non-Sterile",{"product_code":207,"device_name":208,"device_class":8,"k510_count":77},"NNY","Sheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile",{"product_code":210,"device_name":211,"device_class":8,"k510_count":77},"NNZ","System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile",{"product_code":213,"device_name":214,"device_class":8,"k510_count":77},"NOA","Device, Paste-On For Incontinence, Non-Sterile",{"510k":216,"classification":217,"enforcement":218,"event":219,"pma":220,"warning_letter":221},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]