[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OJI":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":115,"syncDates":116,"translation":30,"marketSummary":30,"recalls":123,"k510s":125,"pmas":127},{"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":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":29,"pma_count":29,"event_count":31},1352,"OJI","Burn Kit With Drug","N","","Unknown","SU","3","This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov\u002Fcdrh\u002Fode\u002Fconvkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":8,"product_code":6,"review_panel":11,"gmp_exempt_flag":8,"third_party_flag":8,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":25,"life_sustain_support_flag":8,"medical_specialty_description":10,"summary_malfunction_reporting":26},{"fei_number":17,"registration_number":23},[18,19,20,21,22],"1000512200","3007307589","1833338","1121142","1928237",[18,19,21,22,24],"1420763","6","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[34,43,52,61,69,77,85,92,100,108],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":40,"vector_similarity":41,"score":42},2250,"熱傷キット","Ⅱ","10516000",0.473684,0.130159,0.678406,0.0327869,{"medical_device_id":44,"generic_name":45,"class_classification":46,"jmdn_code":47,"name_similarity":48,"definition_similarity":49,"vector_similarity":50,"score":51},510,"創傷被覆・保護材キット","Ⅲ","34059000",0.225806,0.108553,0.645886,0.0315136,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":58,"vector_similarity":59,"score":60},3735,"骨内医薬品注入キット","Ⅰ","18009000",0.230769,0.185596,0.603844,0.0278201,{"medical_device_id":62,"generic_name":63,"class_classification":55,"jmdn_code":64,"name_similarity":65,"definition_similarity":66,"vector_similarity":67,"score":68},3811,"薬剤付再使用可能な救急キット","44039000",0.152542,0.183168,0.607219,0.0240219,{"medical_device_id":70,"generic_name":71,"class_classification":55,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},3817,"熱傷用ラップ","36093000",0.26087,0.190104,0.54186,0.016129,{"medical_device_id":78,"generic_name":79,"class_classification":37,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},2268,"汎用救急蘇生用救急キット","36690000",0.0645161,0.182292,0.639878,0.015873,{"medical_device_id":86,"generic_name":87,"class_classification":55,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":84},3812,"熱傷被覆・保護材","11322101",0.269231,0.105802,0.543534,{"medical_device_id":93,"generic_name":94,"class_classification":37,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},2169,"点滴開始キット","33963000",0.117647,0.136213,0.628397,0.015625,{"medical_device_id":101,"generic_name":102,"class_classification":37,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},1866,"温熱療法用キット","70215000",0.129032,0.147222,0.626584,0.0153846,{"medical_device_id":109,"generic_name":110,"class_classification":37,"jmdn_code":111,"name_similarity":48,"definition_similarity":112,"vector_similarity":113,"score":114},2062,"創部用ドレナージキット","35824102",0.0844156,0.576889,0.0151515,[],{"510k":117,"classification":118,"enforcement":119,"event":120,"pma":121,"warning_letter":122},"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","2026-08-20T03:28:02.95+00:00",{"items":124,"total":29},[],{"items":126,"total":29},[],{"items":128,"total":29},[]]