[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PPJ":3},{"classification":4,"mappedDevices":38,"similarCandidates":39,"relatedClassifications":121,"syncDates":166},{"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":35,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":36,"pma_count":36,"event_count":36},7069,"PPJ","Peritoneal Dialysis Administration Kit","2","876.5630","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":32,"device_class":8,"implant_flag":33,"product_code":6,"review_panel":10,"gmp_exempt_flag":33,"third_party_flag":33,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":32,"life_sustain_support_flag":33,"medical_specialty_description":11,"summary_malfunction_reporting":34},{"fei_number":17,"registration_number":27},[18,19,20,21,22,23,24,25,26],"3013666218","3004111573","3002902735","1643817","1000512168","3001236905","3000206435","3007329020","3009888344",[18,19,28,21,25,29,26,30,31],"1423537","2030624","9616088","1061124","","N","Eligible","2026-08-18T05:52:53.878886+00:00",0,null,[],[40,49,57,65,73,81,90,98,105,113],{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},823,"腹膜灌流用カテーテルイントロデューサキット","Ⅲ","16992000",0.56,0.118211,0.709701,0.0327869,{"medical_device_id":50,"generic_name":51,"class_classification":43,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},824,"腹膜灌流用チューブセット","35000000",0.416667,0.193299,0.660683,0.0303658,{"medical_device_id":58,"generic_name":59,"class_classification":43,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},536,"腹膜洗浄キット","12996009",0.413043,0.091195,0.669958,0.03031,{"medical_device_id":66,"generic_name":67,"class_classification":43,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},820,"自動腹膜灌流用装置","11226000",0.381818,0.125683,0.66746,0.0296443,{"medical_device_id":74,"generic_name":75,"class_classification":43,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},829,"腹膜灌流用回路及び関連用具セット","70592000",0.328358,0.147222,0.6705,0.0291385,{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},2069,"腹腔胸腔用カテーテルイントロデューサキット","Ⅱ","70316000",0.311475,0.0933735,0.670749,0.02886,{"medical_device_id":91,"generic_name":92,"class_classification":43,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},827,"自動腹膜灌流装置用回路及び関連用具セット","70590000",0.285714,0.164456,0.674472,0.0287873,{"medical_device_id":99,"generic_name":100,"class_classification":43,"jmdn_code":101,"name_similarity":53,"definition_similarity":102,"vector_similarity":103,"score":104},821,"腹膜透析用カテーテル","34921000",0.181474,0.633093,0.0284455,{"medical_device_id":106,"generic_name":107,"class_classification":43,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":112},1110,"腹膜透析用治療計画プログラム","41049003",0.322581,0.16895,0.660888,0.0282587,{"medical_device_id":114,"generic_name":115,"class_classification":84,"jmdn_code":116,"name_similarity":117,"definition_similarity":118,"vector_similarity":119,"score":120},2037,"腹膜灌流用カテーテルガイドワイヤ","35094032",0.344828,0.107034,0.640512,0.0275875,[122,126,130,134,138,142,146,150,154,157,160,163],{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"KDJ","Set, Administration, For Peritoneal Dialysis, Disposable",113,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"FKX","System, Peritoneal, Automatic Delivery",83,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"FJS","Catheter, Peritoneal, Long-Term Indwelling",48,{"product_code":135,"device_name":136,"device_class":8,"k510_count":137},"FKO","Catheter, Peritoneal Dialysis, Single Use",16,{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"PNG","Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling",15,{"product_code":143,"device_name":144,"device_class":8,"k510_count":145},"KPF","System, Dialysate Delivery, Semi-Automatic, Peritoneal",13,{"product_code":147,"device_name":148,"device_class":8,"k510_count":149},"MLW","Warmer, Peritoneal Dialysate",6,{"product_code":151,"device_name":152,"device_class":8,"k510_count":153},"KPP","Peritoneal Dialysate Filter",3,{"product_code":155,"device_name":156,"device_class":8,"k510_count":36},"PPK","Peritoneal Dialysis Tubing Kit",{"product_code":158,"device_name":159,"device_class":8,"k510_count":36},"PTU","Catheter, Peritoneal, Long-Term Indwelling, Exempt",{"product_code":161,"device_name":162,"device_class":8,"k510_count":36},"PTV","Catheter, Peritoneal Dialysis, Single Use, Exempt",{"product_code":164,"device_name":165,"device_class":8,"k510_count":36},"PTW","System, Peritoneal, Automatic Delivery, Exempt",{"510k":167,"classification":168,"enforcement":169,"event":170,"pma":171,"warning_letter":172},"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"]