[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PQE":3},{"classification":4,"mappedDevices":57,"similarCandidates":58,"relatedClassifications":139,"syncDates":174},{"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":52,"updated_at":53,"recall_count":54,"latest_recall_date":55,"k510_count":56,"pma_count":56,"event_count":54},1647,"PQE","Ostomy Care Kit","1","876.5900","GU","Gastroenterology, Urology","7","This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FGuidanceDocuments\u002Fucm080217.pdf.  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":49,"device_class":8,"implant_flag":50,"product_code":6,"review_panel":10,"gmp_exempt_flag":50,"third_party_flag":50,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":49,"life_sustain_support_flag":50,"medical_specialty_description":11,"summary_malfunction_reporting":51},{"fei_number":17,"registration_number":41},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"3014016843","1000219637","3010657142","3007329020","3003348807","3012465068","3009888344","3004111573","1643817","3008806809","3020879941","1480288","1000512168","3001236905","1119193","3043106340","3011987967","3003172243","3002902735","1000317571","3002806731","3003264198","3008262278",[18,20,21,22,23,24,42,25,43,26,44,45,27,28,29,46,32,33,47,48,34,37,40],"9610694","1423537","1061124","9618003","2320961","9616088","1058584","","N","Ineligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",1,"2018-02-14",0,[],[59,68,77,85,93,101,110,117,124,131],{"medical_device_id":60,"generic_name":61,"class_classification":62,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67},3650,"ストーマ用洗浄キット","Ⅰ","37716000",0.407407,0.147632,0.657514,0.0327869,{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},1960,"輪状甲状膜切開キット","Ⅱ","15028000",0.296296,0.157182,0.60503,0.027365,{"medical_device_id":78,"generic_name":79,"class_classification":71,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":84},2829,"歯科根管ポスト成形品キット","70924000",0.166667,0.163842,0.622982,0.0261207,{"medical_device_id":86,"generic_name":87,"class_classification":71,"jmdn_code":88,"name_similarity":89,"definition_similarity":90,"vector_similarity":91,"score":92},1721,"腎盂鏡検査キット","32083000",0.148148,0.197297,0.613029,0.0240981,{"medical_device_id":94,"generic_name":95,"class_classification":62,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},3822,"単回使用クラスⅠ処置キット","33961001",0.117647,0.168067,0.650324,0.016129,{"medical_device_id":102,"generic_name":103,"class_classification":104,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.115385,0.167614,0.646142,0.015873,{"medical_device_id":111,"generic_name":112,"class_classification":71,"jmdn_code":113,"name_similarity":114,"definition_similarity":115,"vector_similarity":116,"score":109},1961,"気管切開キット","35403000",0.28,0.130952,0.578983,{"medical_device_id":118,"generic_name":119,"class_classification":71,"jmdn_code":120,"name_similarity":114,"definition_similarity":121,"vector_similarity":122,"score":123},2166,"動脈切開キット","18026000",0.114943,0.553269,0.015625,{"medical_device_id":125,"generic_name":126,"class_classification":71,"jmdn_code":127,"name_similarity":128,"definition_similarity":129,"vector_similarity":130,"score":123},2198,"産科用麻酔キット","33595000",0.135135,0.136126,0.639128,{"medical_device_id":132,"generic_name":133,"class_classification":71,"jmdn_code":134,"name_similarity":135,"definition_similarity":136,"vector_similarity":137,"score":138},1813,"骨盤検査キット","34122000",0.114286,0.124661,0.629328,0.0153846,[140,144,148,151,155,158,162,165,168,171],{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"EXB","Collector, Ostomy",102,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"EZQ","Pouch, Colostomy",6,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"EZR","Cement, Stomal Appliance, Ostomy",{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"EXE","Protector, Ostomy",3,{"product_code":156,"device_name":157,"device_class":8,"k510_count":154},"FON","Bag, Drainage, With Adhesive, Ostomy",{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"GDS","Bag, Stomal",2,{"product_code":163,"device_name":164,"device_class":8,"k510_count":54},"EXA","Selector, Size, Ostomy",{"product_code":166,"device_name":167,"device_class":8,"k510_count":54},"EZS","Appliance, Colostomy, Disposable",{"product_code":169,"device_name":170,"device_class":8,"k510_count":56},"EXG","Bag, Urine Collecting, Ureterostomy",{"product_code":172,"device_name":173,"device_class":8,"k510_count":56},"EXH","Bag, Urinary, Ileostomy",{"510k":175,"classification":176,"enforcement":177,"event":178,"pma":179,"warning_letter":180},"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"]