[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OKI":3},{"classification":4,"mappedDevices":46,"similarCandidates":47,"relatedClassifications":128,"syncDates":217},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":40,"updated_at":41,"recall_count":42,"latest_recall_date":43,"k510_count":44,"pma_count":44,"event_count":45},1478,"OKI","Emergency Response Safety Kit","2","878.4040","SU","General, Plastic Surgery","HO","7","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":17,"definition":14,"device_name":7,"review_code":37,"device_class":8,"implant_flag":38,"product_code":6,"review_panel":12,"gmp_exempt_flag":38,"third_party_flag":38,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":37,"life_sustain_support_flag":38,"medical_specialty_description":11,"summary_malfunction_reporting":39},{"fei_number":18,"registration_number":32},[19,20,21,22,23,24,25,26,27,28,29,30,31],"1314417","3004111573","3002902735","1643817","3004213967","1000512168","3043668807","3001236905","3007329020","3009888344","3005798963","3006108746","3003770530",[19,20,33,22,25,27,34,28,29,30,31,35,36],"1423537","8030673","9616088","1061124","","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",5,"2026-02-04",0,28,[],[48,57,65,73,81,89,98,106,114,121],{"medical_device_id":49,"generic_name":50,"class_classification":51,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},2268,"汎用救急蘇生用救急キット","Ⅱ","36690000",0.305085,0.182292,0.65869,0.0325225,{"medical_device_id":58,"generic_name":59,"class_classification":51,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},2262,"アナフィラキシー用救急キット","16160000",0.304348,0.184729,0.644612,0.032002,{"medical_device_id":66,"generic_name":67,"class_classification":51,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},2267,"心肺救急蘇生用救急キット","35693000",0.278689,0.131054,0.64275,0.031498,{"medical_device_id":74,"generic_name":75,"class_classification":51,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},2796,"歯科用救急キット","44406000",0.378378,0.214118,0.602275,0.0308862,{"medical_device_id":82,"generic_name":83,"class_classification":51,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},2254,"薬剤なし単回使用救急キット","44047000",0.235294,0.195846,0.63253,0.0305504,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},3810,"薬剤なし再使用可能な救急キット","Ⅰ","43000000",0.242424,0.210959,0.627671,0.0305361,{"medical_device_id":99,"generic_name":100,"class_classification":92,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},3811,"薬剤付再使用可能な救急キット","44039000",0.253968,0.183168,0.612998,0.03031,{"medical_device_id":107,"generic_name":108,"class_classification":51,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},2169,"点滴開始キット","33963000",0.113636,0.136213,0.624564,0.0151515,{"medical_device_id":5,"generic_name":115,"class_classification":51,"jmdn_code":116,"name_similarity":117,"definition_similarity":118,"vector_similarity":119,"score":120},"誘発反応測定装置","70068000",0.222222,0.101538,0.50683,0.0147059,{"medical_device_id":122,"generic_name":123,"class_classification":51,"jmdn_code":124,"name_similarity":125,"definition_similarity":126,"vector_similarity":127,"score":120},2201,"硬膜外麻酔キット","34842002",0.1,0.113402,0.611156,[129,133,137,141,146,150,154,158,162,166,170,174,178,181,184,188,192,196,199,202,205,208,211,214],{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"FXX","Mask, Surgical",607,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"FYA","Gown, Surgical",297,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"FYC","Gown, Isolation, Surgical",68,{"product_code":142,"device_name":143,"device_class":144,"k510_count":145},"LYU","Accessory, Surgical Apparel","1",56,{"product_code":147,"device_name":148,"device_class":144,"k510_count":149},"FXP","Cover, Shoe, Operating-Room",36,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"MSH","Respirator, Surgical",35,{"product_code":155,"device_name":156,"device_class":144,"k510_count":157},"FYF","Cap, Surgical",32,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"FXY","Hood, Surgical",13,{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"QPC","Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection",10,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"OXZ","Pediatric\u002FChild Facemask",9,{"product_code":171,"device_name":172,"device_class":144,"k510_count":173},"FYE","Dress, Surgical",7,{"product_code":175,"device_name":176,"device_class":144,"k510_count":177},"FXO","Suit, Surgical",6,{"product_code":179,"device_name":180,"device_class":8,"k510_count":177},"FYB","Gown, Patient",{"product_code":182,"device_name":183,"device_class":8,"k510_count":177},"ONT","N95 Respirator With Antimicrobial\u002FAntiviral Agent",{"product_code":185,"device_name":186,"device_class":8,"k510_count":187},"OUK","Surgical Mask With Antimicrobial\u002FAntiviral Agent",4,{"product_code":189,"device_name":190,"device_class":144,"k510_count":191},"BWP","Shoe And Shoe Cover, Conductive",3,{"product_code":193,"device_name":194,"device_class":144,"k510_count":195},"FXW","Shoes, Operating-Room",1,{"product_code":197,"device_name":198,"device_class":8,"k510_count":195},"QBW","Surgical Apparel With Material Claims",{"product_code":200,"device_name":201,"device_class":144,"k510_count":44},"FXZ","Helmet, Surgical",{"product_code":203,"device_name":204,"device_class":144,"k510_count":44},"OEA","Non-Surgical Gown",{"product_code":206,"device_name":207,"device_class":8,"k510_count":44},"OKF","Body Fluid Disposal Kit",{"product_code":209,"device_name":210,"device_class":8,"k510_count":44},"OKG","Body Fluid Clean Up Kit",{"product_code":212,"device_name":213,"device_class":8,"k510_count":44},"OKH","Body Fluids Barrier Kit",{"product_code":215,"device_name":216,"device_class":8,"k510_count":44},"QSO","Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy Drugs",{"510k":218,"classification":219,"enforcement":220,"event":221,"pma":222,"warning_letter":223},"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"]