[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KDW":3},{"classification":4,"mappedDevices":51,"similarCandidates":52,"relatedClassifications":124,"syncDates":154},{"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":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":47,"event_count":50},5217,"KDW","Container, Specimen Mailer And Storage, Temperature Controlled, Sterile","1","864.3250","PA","Pathology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":43,"product_code":6,"review_panel":10,"gmp_exempt_flag":43,"third_party_flag":43,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":43,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"k_number":17,"fei_number":22,"registration_number":40},[18,19,20,21],"K931474","K913967","K970580","K951122",[23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"1000110890","3002836339","2244900","3006210673","3013188547","3030708766","1219930","3017210488","3011945100","3006897996","3007544634","3030626857","3018094310","2647580","3013557562","3010194621","3014150341",[25,26,27,28,29,41,30,42,31,32,33,34,35,36,37,38,39],"1055358","1226230","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,11,[],[53,61,69,76,83,90,97,104,111,117],{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":47,"vector_similarity":59,"score":60},3719,"組織培養用試料調整容器","Ⅰ","70369000",0.197674,0.68413,0.0306792,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":47,"vector_similarity":67,"score":68},1108,"中心静脈留置型経皮的体温調節装置コントロールユニット","Ⅲ","44709003",0.252525,0.607366,0.0278937,{"medical_device_id":70,"generic_name":71,"class_classification":56,"jmdn_code":72,"name_similarity":73,"definition_similarity":47,"vector_similarity":74,"score":75},3649,"一時的使用胃食道用滅菌済みチューブ及びカテーテル","70231000",0.223404,0.609719,0.0274328,{"medical_device_id":77,"generic_name":78,"class_classification":56,"jmdn_code":79,"name_similarity":80,"definition_similarity":47,"vector_similarity":81,"score":82},3589,"低温温度制御装置","16538000",0.253333,0.579761,0.0163934,{"medical_device_id":84,"generic_name":85,"class_classification":56,"jmdn_code":86,"name_similarity":87,"definition_similarity":47,"vector_similarity":88,"score":89},3581,"微生物培養装置","70189000",0.0361446,0.657947,0.016129,{"medical_device_id":91,"generic_name":92,"class_classification":64,"jmdn_code":93,"name_similarity":94,"definition_similarity":47,"vector_similarity":95,"score":96},886,"モータ付自動絞り加速装置用コリメータ","38138000",0.229167,0.548179,0.015873,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":47,"vector_similarity":103,"score":96},2061,"経血用収集器","Ⅱ","18132000",0.0886076,0.655025,{"medical_device_id":105,"generic_name":106,"class_classification":64,"jmdn_code":107,"name_similarity":108,"definition_similarity":47,"vector_similarity":109,"score":110},722,"人工心肺用温度コントロールユニット","36374000",0.22619,0.547619,0.015625,{"medical_device_id":112,"generic_name":113,"class_classification":56,"jmdn_code":114,"name_similarity":115,"definition_similarity":47,"vector_similarity":116,"score":110},3911,"哺乳瓶保温器","70479000",0.0240964,0.643195,{"medical_device_id":118,"generic_name":119,"class_classification":100,"jmdn_code":120,"name_similarity":121,"definition_similarity":47,"vector_similarity":122,"score":123},3176,"気管支肺胞洗浄用カテーテル","32158002",0.05,0.642093,0.0153846,[125,129,133,136,139,142,145,148,151],{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"FMH","Container, Specimen, Sterile",23,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"KDT","Container, Specimen Mailer And Storage, Sterile",12,{"product_code":134,"device_name":135,"device_class":8,"k510_count":47},"NNI","Container, Specimen, Non-Sterile",{"product_code":137,"device_name":138,"device_class":8,"k510_count":47},"NNK","Container, Specimen Mailer And Storage, Non-Sterile",{"product_code":140,"device_name":141,"device_class":8,"k510_count":47},"NNL","Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile",{"product_code":143,"device_name":144,"device_class":8,"k510_count":47},"OHZ","Urine Transport Kit (Excludes Hiv Testing)",{"product_code":146,"device_name":147,"device_class":8,"k510_count":47},"OIA","Neonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)",{"product_code":149,"device_name":150,"device_class":8,"k510_count":47},"OIB","Blood And Urine Collection Kit (Excludes Hiv Testing)",{"product_code":152,"device_name":153,"device_class":8,"k510_count":47},"OIE","Urine Collection Kit (Excludes Hiv Testing)",{"510k":155,"classification":156,"enforcement":157,"event":158,"pma":159,"warning_letter":160},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]