[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NZJ":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":125,"syncDates":130},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":39,"pma_count":41,"event_count":42},1370,"NZJ","Respirator, N95, For Use By The General Public In Public Health Medical Emergencies","2","880.6260","HO","General Hospital","1","It is intended to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates during public health medical emergencies, such as influenza pandemic and also protects the wearer from splash and spray of body fluids.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":34,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":34,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":20,"registration_number":33},[18,19],"DEN060009","K083176",[21,22,23,24,25,26,27,28,29,30,31,32],"3005236311","3008048818","3006942307","2110898","3045816954","3015997711","2427500","3011310668","3016678387","3012104670","3010141571","3008770708",[21,22,23,24,25,26,27,28,29,30,31,32],"","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",2,"2020-10-07",0,4,[],[45,54,63,71,79,87,95,102,110,117],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},770,"汎用人工呼吸器","Ⅲ","70561000",0.2,0.181604,0.685088,0.0294691,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},2268,"汎用救急蘇生用救急キット","Ⅱ","36690000",0.265957,0.186589,0.666816,0.0281581,{"medical_device_id":64,"generic_name":65,"class_classification":57,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},2418,"救急蘇生マスク","36066000",0.045977,0.189349,0.746272,0.0163934,{"medical_device_id":72,"generic_name":73,"class_classification":48,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},780,"呼気肺人工蘇生器","17141000",0.0918367,0.244186,0.745287,0.016129,{"medical_device_id":80,"generic_name":81,"class_classification":82,"jmdn_code":83,"name_similarity":84,"definition_similarity":85,"vector_similarity":86,"score":78},4367,"医科用捲綿子","Ⅰ","10172000",0.24359,0.133641,0.625215,{"medical_device_id":88,"generic_name":89,"class_classification":48,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},793,"医用ガス調整器","36327000",0.2125,0.159341,0.623347,0.015873,{"medical_device_id":96,"generic_name":97,"class_classification":82,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":94},3926,"人工呼吸器用マスク","70564000",0.047619,0.207547,0.739073,{"medical_device_id":103,"generic_name":104,"class_classification":57,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},2414,"エアロゾル非再呼吸式マスク","35172000",0.0412371,0.225071,0.717526,0.015625,{"medical_device_id":111,"generic_name":112,"class_classification":57,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":109},3019,"胸部集団検診用一体型X線診断装置用プログラム","37627072",0.204918,0.190323,0.538132,{"medical_device_id":118,"generic_name":119,"class_classification":57,"jmdn_code":120,"name_similarity":121,"definition_similarity":122,"vector_similarity":123,"score":124},2416,"部分再呼吸式マスク","35174000",0.0543478,0.173913,0.704225,0.0153846,[126],{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"ORW","N95 Respirator With Antimicrobial\u002FAntiviral Agent For Use By The General Public In Public Health Medical Emergencies",1,{"510k":131,"classification":132,"enforcement":133,"event":134,"pma":135,"warning_letter":136},"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"]