[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-MYY":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":102,"syncDates":103,"translation":110,"marketSummary":116,"recalls":131,"k510s":133,"pmas":135},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":8,"definition":9,"implant_flag":12,"life_sustain_support_flag":12,"gmp_exempt_flag":12,"raw":13,"created_at":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":24,"pma_count":24,"event_count":26},2333,"MYY","Separator, Semi-Automated, Blood Component","1","","Unknown","HE",false,{"openfda":14,"definition":9,"device_name":7,"review_code":9,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":11,"gmp_exempt_flag":20,"third_party_flag":20,"medical_specialty":9,"regulation_number":9,"submission_type_id":8,"unclassified_reason":9,"life_sustain_support_flag":20,"medical_specialty_description":10,"summary_malfunction_reporting":21},{"fei_number":15,"registration_number":18},[16,17],"3011720361","1000117351",[19,16],"1722028","N","Eligible","2026-08-18T05:52:49.993647+00:00","2026-08-24T02:00:47.808424+00:00",0,null,13,[],[29,37,45,52,60,67,74,81,88,95],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},2991,"血液成分分離用装置","Ⅱ","58329002",0.489796,0.801434,0.032002,{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},1082,"血液成分分離キット","Ⅲ","58331003",0.489362,0.789024,0.0310245,{"medical_device_id":46,"generic_name":47,"class_classification":40,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},742,"膜型血漿成分分離器","70531000",0.363636,0.780668,0.03031,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":24,"vector_similarity":58,"score":59},3566,"血清用血液分離装置","Ⅰ","17106000",0.232558,0.797901,0.0288981,{"medical_device_id":61,"generic_name":62,"class_classification":55,"jmdn_code":63,"name_similarity":64,"definition_similarity":24,"vector_similarity":65,"score":66},3564,"血球分離装置","15113000",0.215686,0.805571,0.0287873,{"medical_device_id":68,"generic_name":69,"class_classification":40,"jmdn_code":70,"name_similarity":71,"definition_similarity":24,"vector_similarity":72,"score":73},442,"フィルタ付血液成分分離バッグ","70358000",0.396552,0.715322,0.0278201,{"medical_device_id":75,"generic_name":76,"class_classification":55,"jmdn_code":77,"name_similarity":78,"definition_similarity":24,"vector_similarity":79,"score":80},3541,"血液像自動分析装置","35479000",0.227273,0.738071,0.0272424,{"medical_device_id":82,"generic_name":83,"class_classification":32,"jmdn_code":84,"name_similarity":85,"definition_similarity":24,"vector_similarity":86,"score":87},2385,"血漿分離用血液回路","70546000",0.22807,0.717711,0.025679,{"medical_device_id":89,"generic_name":90,"class_classification":55,"jmdn_code":91,"name_similarity":92,"definition_similarity":24,"vector_similarity":93,"score":94},4014,"歯間分離器","42340000",0.222222,0.719346,0.025487,{"medical_device_id":96,"generic_name":97,"class_classification":55,"jmdn_code":98,"name_similarity":99,"definition_similarity":24,"vector_similarity":100,"score":101},3539,"手動式血球計数装置","35103000",0.205882,0.736164,0.0254633,[],{"510k":104,"classification":105,"enforcement":106,"event":107,"pma":108,"warning_letter":109},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":111,"definition_ja":25,"commentary_ja":112,"model_name":113,"source_hash":114,"reviewed_by":25,"reviewed_at":25,"created_at":115,"updated_at":115},"半自動血液成分分離装置","本機器は、血液を血漿や血球などの成分に半自動的に分離する装置です。米国ではクラスIに分類されており、これは相対的にリスクが低い医療機器であることを示し、市販前届出（510(k)）による審査区分に該当します。","claude-sonnet-5","3ff56c1e9b754b65e51dbff56441851e6398fbe9137f96185dc2cae271066cdf","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":117,"stats":118,"stats_hash":129,"model_name":113,"created_at":130,"updated_at":130},"本製品コードについては、510(k)およびPMAの届出・承認実績は確認されていません。不具合報告（MDR）は累計約10件で、直近5年間の報告件数も同数となっており、その大半が不具合（Malfunction）によるもので、死亡報告は0件、傷害報告は1件です。回収（リコール）については、クラスI・II・IIIのいずれも報告は確認されていません。",{"pma":119,"k510":120,"as_of":121,"events":122,"recalls":126,"top_problems":128},{"latest":25,"originals":24,"supplements":24},{"total":24,"last5y":24,"latest":25,"applicants":24},"2026-08",{"death":24,"other":24,"total":26,"injury":123,"last5y":26,"malfunction":124,"latest_month":125},1,12,"2026-03",{"total":24,"last5y":24,"latest":25,"class_i":24,"class_ii":24,"class_iii":24,"top_root_causes":127},[],[],"ee51d6e4075dca5e34fae084dcdde058f322f294bca28b9abf80ddc218a03e60","2026-08-24T04:57:04.90455+00:00",{"items":132,"total":24},[],{"items":134,"total":24},[],{"items":136,"total":24},[]]