[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DMP":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":102,"syncDates":138},{"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":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":28,"pma_count":26,"event_count":26},6857,"DMP","Digoxin Control Serum, Ria","1","862.3280","TX","Clinical Toxicology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":22,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":23},{"k_number":17},[18,19,20,21],"K953393","K770411","K973973","K780889","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,[],[31,39,47,54,61,68,75,82,89,96],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":26,"vector_similarity":37,"score":38},2556,"トレパンシステムコントロールユニット","Ⅱ","43928000",0.195652,0.552698,0.0292063,{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":26,"vector_similarity":45,"score":46},692,"透析用監視装置","Ⅲ","36424000",0.22,0.549381,0.0288934,{"medical_device_id":48,"generic_name":49,"class_classification":42,"jmdn_code":50,"name_similarity":51,"definition_similarity":26,"vector_similarity":52,"score":53},456,"注射筒輸液ポンプコントロールユニット","37217000",0.173077,0.558122,0.0281746,{"medical_device_id":55,"generic_name":56,"class_classification":42,"jmdn_code":57,"name_similarity":58,"definition_similarity":26,"vector_similarity":59,"score":60},459,"医薬品注入コントローラ","11010000",0.186047,0.548325,0.0272894,{"medical_device_id":62,"generic_name":63,"class_classification":34,"jmdn_code":64,"name_similarity":65,"definition_similarity":26,"vector_similarity":66,"score":67},1515,"心臓内オキシメータモジュール","37172000",0.0377358,0.570318,0.0163934,{"medical_device_id":69,"generic_name":70,"class_classification":34,"jmdn_code":71,"name_similarity":72,"definition_similarity":26,"vector_similarity":73,"score":74},2251,"局所管理フォーム状創傷被覆・保護材","11323002",0.2,0.464836,0.016129,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":80,"definition_similarity":26,"vector_similarity":81,"score":74},3598,"再使用可能な皮下注射ポート用針","Ⅰ","17180001",0.0277778,0.565334,{"medical_device_id":83,"generic_name":84,"class_classification":42,"jmdn_code":85,"name_similarity":86,"definition_similarity":26,"vector_similarity":87,"score":88},450,"オキシトシン注射筒輸液ポンプ","16167000",0.0363636,0.565089,0.015873,{"medical_device_id":90,"generic_name":91,"class_classification":42,"jmdn_code":92,"name_similarity":93,"definition_similarity":26,"vector_similarity":94,"score":95},337,"ヘパリン使用体表面電気刺激装置用電極","34374203",0.0694444,0.562584,0.015625,{"medical_device_id":97,"generic_name":98,"class_classification":34,"jmdn_code":99,"name_similarity":100,"definition_similarity":26,"vector_similarity":101,"score":95},2446,"酸素コントローラ","70577000",0.189189,0.519964,[103,107,111,115,119,122,125,129,132,135],{"product_code":104,"device_name":105,"device_class":8,"k510_count":106},"DIF","Drug Mixture Control Materials",202,{"product_code":108,"device_name":109,"device_class":8,"k510_count":110},"LAS","Drug Specific Control Materials",83,{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"DKC","Alcohol Control Materials",11,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"DIE","Heavy Metals Control Materials",5,{"product_code":120,"device_name":121,"device_class":8,"k510_count":28},"LAW","Theophylline Control Materials",{"product_code":123,"device_name":124,"device_class":8,"k510_count":28},"LAZ","N-Acetylprocainamide Control Materials",{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"DJK","Digitoxin Control Serum, Ria",1,{"product_code":130,"device_name":131,"device_class":8,"k510_count":128},"LAX","Lidocaine Control Materials",{"product_code":133,"device_name":134,"device_class":8,"k510_count":128},"LBA","Procainamide Control Materials",{"product_code":136,"device_name":137,"device_class":8,"k510_count":26},"LAY","Methotrexate Control Materials",{"510k":139,"classification":140,"enforcement":141,"event":142,"pma":143,"warning_letter":144},"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","2026-08-18T06:42:29.411+00:00"]