[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GIL":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":110,"syncDates":140},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":37},6183,"GIL","Plasma, Fibrinogen Control","2","864.7340","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"k_number":17,"fei_number":26,"registration_number":30},[18,19,20,21,22,23,24,25],"K915462","K934741","K946265","K951012","K946193","K935598","K833352","K962407",[27,28,29],"3001644026","3004445302","3014150341",[31,32,29],"2032900","9610806","N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",0,null,8,[],[42,50,58,65,72,79,85,92,97,103],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":37,"vector_similarity":48,"score":49},3748,"血漿融解装置","Ⅰ","43434000",0.179487,0.634449,0.0299107,{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":37,"vector_similarity":56,"score":57},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","Ⅲ","44709003",0.153846,0.633721,0.0270125,{"medical_device_id":59,"generic_name":60,"class_classification":53,"jmdn_code":61,"name_similarity":62,"definition_similarity":37,"vector_similarity":63,"score":64},1089,"自己検査用血液凝固分析器","56687003",0.057971,0.664167,0.0163934,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":37,"vector_similarity":71,"score":64},2446,"酸素コントローラ","Ⅱ","70577000",0.257143,0.596939,{"medical_device_id":73,"generic_name":74,"class_classification":53,"jmdn_code":75,"name_similarity":76,"definition_similarity":37,"vector_similarity":77,"score":78},337,"ヘパリン使用体表面電気刺激装置用電極","34374203",0.0547945,0.642324,0.016129,{"medical_device_id":80,"generic_name":81,"class_classification":68,"jmdn_code":82,"name_similarity":83,"definition_similarity":37,"vector_similarity":84,"score":78},2251,"局所管理フォーム状創傷被覆・保護材","11323002",0.2,0.577865,{"medical_device_id":86,"generic_name":87,"class_classification":53,"jmdn_code":88,"name_similarity":89,"definition_similarity":37,"vector_similarity":90,"score":91},393,"ヘパリン使用血管留置用センサ","70273000",0.0461538,0.636345,0.015873,{"medical_device_id":93,"generic_name":94,"class_classification":45,"jmdn_code":95,"name_similarity":83,"definition_similarity":37,"vector_similarity":96,"score":91},3589,"低温温度制御装置","16538000",0.550287,{"medical_device_id":98,"generic_name":99,"class_classification":68,"jmdn_code":100,"name_similarity":83,"definition_similarity":37,"vector_similarity":101,"score":102},2901,"電動器具トルクコントロール装置","43894000",0.557,0.015625,{"medical_device_id":104,"generic_name":105,"class_classification":53,"jmdn_code":106,"name_similarity":107,"definition_similarity":37,"vector_similarity":108,"score":109},456,"注射筒輸液ポンプコントロールユニット","37217000",0.196078,0.580251,0.0153846,[111,115,119,123,127,131,134,137],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"KQJ","System, Fibrinogen Determination",28,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"GIS","Test, Fibrinogen",13,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"GFX","Fibrinogen Standard",3,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"DAT","Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control",2,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"GFK","Fibrinogen Determination Standards And Controls",1,{"product_code":132,"device_name":133,"device_class":8,"k510_count":37},"DAR","Fibrinogen And Split Products, Rhodamine, Antigen, Antiserum, Control",{"product_code":135,"device_name":136,"device_class":8,"k510_count":37},"DAX","Fibrinogen And Split Products, Fitc, Antigen, Antiserum, Control",{"product_code":138,"device_name":139,"device_class":8,"k510_count":37},"DAZ","Fibrinogen And Split Products, Antigen, Antiserum, Control",{"510k":141,"classification":142,"enforcement":143,"event":144,"pma":145,"warning_letter":146},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]