[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PPG":3},{"classification":4,"mappedDevices":45,"similarCandidates":46,"relatedClassifications":131,"syncDates":227},{"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":39,"updated_at":40,"recall_count":41,"latest_recall_date":42,"k510_count":43,"pma_count":43,"event_count":44},5002,"PPG","Urinary Drainage Collection Kit","2","876.5130","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":36,"device_class":8,"implant_flag":37,"product_code":6,"review_panel":10,"gmp_exempt_flag":37,"third_party_flag":37,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":36,"life_sustain_support_flag":37,"medical_specialty_description":11,"summary_malfunction_reporting":38},{"fei_number":17,"registration_number":30},[18,19,20,21,22,23,24,25,26,27,28,29],"3009086335","3004111573","3002902735","1643817","3002806934","1000512168","1921846","3001236905","3007329020","3003076831","3009888344","1928237",[18,19,31,21,32,24,26,33,28,29,34,35],"1423537","9612030","2032112","9616088","1061124","","N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",1,"2023-01-18",0,6,[],[47,56,64,73,82,90,98,106,114,122],{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":55},2062,"創部用ドレナージキット","Ⅱ","35824102",0.351351,0.0782609,0.658106,0.0312576,{"medical_device_id":57,"generic_name":58,"class_classification":50,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},2256,"切開・ドレナージキット","35118000",0.394737,0.122093,0.634854,0.0306792,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},418,"ヘパリン使用創部用ドレナージキット","Ⅲ","35824203",0.326531,0.107345,0.655966,0.0305504,{"medical_device_id":74,"generic_name":75,"class_classification":76,"jmdn_code":77,"name_similarity":78,"definition_similarity":79,"vector_similarity":80,"score":81},129,"脳室用ドレナージキット","Ⅳ","36151000",0.302326,0.161644,0.633802,0.0294691,{"medical_device_id":83,"generic_name":84,"class_classification":50,"jmdn_code":85,"name_similarity":86,"definition_similarity":87,"vector_similarity":88,"score":89},1992,"泌尿器用洗浄キット","14301000",0.384615,0.105105,0.628845,0.0292869,{"medical_device_id":91,"generic_name":92,"class_classification":50,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},1988,"泌尿器用カテーテルイントロデューサキット","32030000",0.192308,0.144654,0.650011,0.025817,{"medical_device_id":99,"generic_name":100,"class_classification":50,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},2307,"単回使用吸引キット","36142000",0.204545,0.166276,0.616215,0.0235424,{"medical_device_id":107,"generic_name":108,"class_classification":50,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},1985,"泌尿器用カテーテル挿入・採尿キット","14292000",0.181818,0.134503,0.682567,0.0163934,{"medical_device_id":115,"generic_name":116,"class_classification":50,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":121},1986,"間欠泌尿器用カテーテルイントロデューサキット","16321000",0.15625,0.120944,0.675007,0.016129,{"medical_device_id":123,"generic_name":124,"class_classification":125,"jmdn_code":126,"name_similarity":127,"definition_similarity":128,"vector_similarity":129,"score":130},3849,"一時的使用膀胱洗浄キット","Ⅰ","10406001",0.172414,0.0956522,0.673397,0.015873,[132,136,139,143,147,151,155,159,162,166,170,174,179,182,185,188,191,194,197,200,203,206,209,212,215,218,221,224],{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"KOD","Catheter, Urological",238,{"product_code":137,"device_name":138,"device_class":8,"k510_count":74},"EZL","Catheter, Retention Type, Balloon",{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"EZD","Catheter, Straight",86,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"GBM","Catheter, Urethral",71,{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"KNY","Accessories, Catheter, G-U",65,{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"FCM","Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)",60,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"EYB","Catheter, Ureteral, Gastro-Urology",28,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"LJH","System, Irrigation, Urological",{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"MJC","Catheter, Urological (Antimicrobial) And Accessories",10,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"EZC","Catheter, Coude",7,{"product_code":171,"device_name":172,"device_class":8,"k510_count":173},"EYC","Catheter, Upper Urinary Tract",5,{"product_code":175,"device_name":176,"device_class":177,"k510_count":178},"EZB","Stylet For Catheter, Gastro-Urology","1",3,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"FGI","Catheter, Urethrographic, Male",{"product_code":183,"device_name":184,"device_class":177,"k510_count":41},"EYK","Connector, Ureteral Catheter",{"product_code":186,"device_name":187,"device_class":8,"k510_count":41},"FGF","Catheter, Ureteral Disposable (X-Ray)",{"product_code":189,"device_name":190,"device_class":8,"k510_count":41},"FGH","Catheter, Double Lumen Female Urethrographic",{"product_code":192,"device_name":193,"device_class":8,"k510_count":41},"NWO","Kit, Catheter, Urinary (Exludes Hiv Testing)",{"product_code":195,"device_name":196,"device_class":177,"k510_count":43},"EYA","Stylet, Ureteral",{"product_code":198,"device_name":199,"device_class":177,"k510_count":43},"EYI","Adaptor, Ureteral Catheter",{"product_code":201,"device_name":202,"device_class":177,"k510_count":43},"EYJ","Holder, Ureteral Catheter",{"product_code":204,"device_name":205,"device_class":37,"k510_count":43},"GBL","Catheter, Ureteral, General & Plastic Surgery",{"product_code":207,"device_name":208,"device_class":8,"k510_count":43},"OHR","Catheter Care Tray",{"product_code":210,"device_name":211,"device_class":8,"k510_count":43},"PPA","Bladder Irrigation Kit",{"product_code":213,"device_name":214,"device_class":8,"k510_count":43},"PPB","Foley Catheter Kit (Excludes Hiv Testing)",{"product_code":216,"device_name":217,"device_class":8,"k510_count":43},"PPC","Male External Catheterization Kit (Excludes Hiv Testing)",{"product_code":219,"device_name":220,"device_class":8,"k510_count":43},"PPD","Universal Drainage Tray",{"product_code":222,"device_name":223,"device_class":8,"k510_count":43},"PPF","Urinary Irrigation Kit",{"product_code":225,"device_name":226,"device_class":8,"k510_count":43},"SCT","Foley Catheters And Accessories With Additional Safety Features",{"510k":228,"classification":229,"enforcement":230,"event":231,"pma":232,"warning_letter":233},"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"]