[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GIZ":3},{"classification":4,"mappedDevices":68,"similarCandidates":69,"relatedClassifications":142,"syncDates":163},{"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":14,"raw":15,"created_at":62,"updated_at":63,"recall_count":64,"latest_recall_date":65,"k510_count":66,"pma_count":67,"event_count":67},4514,"GIZ","Plasma, Control, Normal","2","864.5425","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":60,"product_code":6,"review_panel":10,"gmp_exempt_flag":60,"third_party_flag":60,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":60,"medical_specialty_description":11,"summary_malfunction_reporting":61},{"k_number":17,"fei_number":38,"registration_number":54},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"K891179","K880712","K924403","K003328","K060968","K893784","K023309","K922021","K893783","K001256","K042941","K932145","K905203","K935254","K984129","K895262","K973274","K941737","K961814","K013708",[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"1928890","1000117401","3013660430","1181121","3005917516","1000340866","2431530","3037000637","2245451","3003565434","3003691680","3001644026","3000210416","1618982","3014150341",[39,41,42,55,44,45,46,56,47,57,58,49,59,52,53],"9610806","8043599","1835316","9710666","1721937","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-18T22:05:38.961415+00:00",1,"2020-01-01",20,0,[],[70,78,86,93,100,107,114,121,128,135],{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":67,"vector_similarity":76,"score":77},3748,"血漿融解装置","Ⅰ","43434000",0.2,0.661162,0.0313188,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":67,"vector_similarity":84,"score":85},2446,"酸素コントローラ","Ⅱ","70577000",0.212121,0.614664,0.0303309,{"medical_device_id":87,"generic_name":88,"class_classification":89,"jmdn_code":90,"name_similarity":75,"definition_similarity":67,"vector_similarity":91,"score":92},743,"吸着型血漿浄化器","Ⅲ","70532000",0.615803,0.0296313,{"medical_device_id":94,"generic_name":95,"class_classification":89,"jmdn_code":96,"name_similarity":97,"definition_similarity":67,"vector_similarity":98,"score":99},756,"膜型血漿分離用装置","36426000",0.184211,0.614265,0.0280063,{"medical_device_id":101,"generic_name":102,"class_classification":89,"jmdn_code":103,"name_similarity":104,"definition_similarity":67,"vector_similarity":105,"score":106},1108,"中心静脈留置型経皮的体温調節装置コントロールユニット","44709003",0.162162,0.64493,0.0272401,{"medical_device_id":108,"generic_name":109,"class_classification":89,"jmdn_code":110,"name_similarity":111,"definition_similarity":67,"vector_similarity":112,"score":113},692,"透析用監視装置","36424000",0.163265,0.634956,0.027109,{"medical_device_id":115,"generic_name":116,"class_classification":89,"jmdn_code":117,"name_similarity":118,"definition_similarity":67,"vector_similarity":119,"score":120},741,"膜型血漿分離器","70530000",0.170732,0.61379,0.0267857,{"medical_device_id":122,"generic_name":123,"class_classification":73,"jmdn_code":124,"name_similarity":125,"definition_similarity":67,"vector_similarity":126,"score":127},3277,"X線自動露出制御器","34311000",0.170213,0.608952,0.0257086,{"medical_device_id":129,"generic_name":130,"class_classification":73,"jmdn_code":131,"name_similarity":132,"definition_similarity":67,"vector_similarity":133,"score":134},3565,"細胞・血漿用血液分離装置","16901000",0.183673,0.60023,0.0252381,{"medical_device_id":136,"generic_name":137,"class_classification":73,"jmdn_code":138,"name_similarity":139,"definition_similarity":67,"vector_similarity":140,"score":141},3589,"低温温度制御装置","16538000",0.166667,0.598842,0.0236695,[143,147,151,155,159],{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"JPA","System, Multipurpose For In Vitro Coagulation Studies",181,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"GGN","Plasma, Coagulation Control",99,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"GGC","Control, Plasma, Abnormal",40,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"LGP","Assay, Alpha-2-Antiplasmin",5,{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"LLG","Kit, Igg, Platelet Associated",2,{"510k":164,"classification":165,"enforcement":166,"event":167,"pma":168,"warning_letter":169},"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"]