[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PPI":3},{"classification":4,"mappedDevices":37,"similarCandidates":38,"relatedClassifications":149,"syncDates":432,"translation":36,"marketSummary":36,"recalls":440,"k510s":442,"pmas":444},{"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":33,"updated_at":34,"recall_count":35,"latest_recall_date":36,"k510_count":35,"pma_count":35,"event_count":35,"total_record_count":35},6699,"PPI","Hemodialysis Tray (Not A Start\u002FStop Kit)","2","876.5820","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":30,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":10,"gmp_exempt_flag":31,"third_party_flag":31,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":30,"life_sustain_support_flag":31,"medical_specialty_description":11,"summary_malfunction_reporting":32},{"fei_number":17,"registration_number":26},[18,19,20,21,22,23,24,25],"1000512168","1625425","3001236905","3002902735","3009888344","1643817","3007329020","3004111573",[27,28,19,29,22,23,24,25],"1423537","9616088","1061124","","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-09-07T05:11:14.284597+00:00",0,null,[],[39,60,72,84,95,103,111,120,128,136],{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47,"id":40,"category_code":48,"category_name":49,"subcategory_name":50,"data_exist":51,"product_count":52,"company_count":53,"market_size":54,"market_size_unit":55,"growth_ratio":56,"average_price":57,"average_price_unit":58,"domestic_ratio":59},2263,"透析開始・終了セット","Ⅱ","32142000",0.380952,0.147727,0.722647,0.0327869,"医04","整形用品","その他の処置用機器",true,4,3,8.09,"億円\u002F年",-37.18,87,"円\u002F個",100,{"medical_device_id":61,"generic_name":62,"class_classification":42,"jmdn_code":63,"name_similarity":64,"definition_similarity":65,"vector_similarity":66,"score":67,"id":61,"category_code":68,"category_name":69,"subcategory_name":70,"data_exist":14,"product_count":71,"company_count":71,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},2169,"点滴開始キット","33963000",0.217391,0.130952,0.669865,0.0308349,"器74","医薬品注入器","採血・輸血用、輸液用器具及び医薬品注入器",1,{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80,"id":73,"category_code":81,"category_name":82,"subcategory_name":83,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},426,"血液透析用コアキシャルフロー型カテーテルイントロデューサキット","Ⅲ","33799100",0.238806,0.121387,0.650569,0.0305504,"器51","医療用嘴管及び体液誘導管","チューブ及びカテーテル",{"medical_device_id":85,"generic_name":86,"class_classification":75,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91,"id":85,"category_code":92,"category_name":93,"subcategory_name":94,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},823,"腹膜灌流用カテーテルイントロデューサキット","16992000",0.169231,0.118211,0.655058,0.0292063,"器07","内臓機能代用器","腹膜灌流用機器及び関連器具",{"medical_device_id":96,"generic_name":97,"class_classification":75,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102,"id":96,"category_code":81,"category_name":82,"subcategory_name":83,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},427,"ウロキナーゼ使用血液透析用コアキシャルフロー型カテーテルイントロデューサキット","33799200",0.227848,0.132768,0.635805,0.0284848,{"medical_device_id":104,"generic_name":105,"class_classification":75,"jmdn_code":106,"name_similarity":107,"definition_similarity":108,"vector_similarity":109,"score":110,"id":104,"category_code":81,"category_name":82,"subcategory_name":83,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},429,"閉鎖式血液透析用カテーテル","42452000",0.20339,0.0787879,0.64034,0.0283702,{"medical_device_id":112,"generic_name":113,"class_classification":75,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":118,"id":112,"category_code":92,"category_name":93,"subcategory_name":119,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},701,"血液透析装置用ピロー圧力アラーム","32124000",0.223881,0.14218,0.635635,0.0280833,"血液体外循環機器",{"medical_device_id":121,"generic_name":122,"class_classification":75,"jmdn_code":123,"name_similarity":124,"definition_similarity":125,"vector_similarity":126,"score":127,"id":121,"category_code":81,"category_name":82,"subcategory_name":83,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},428,"植込み型血液透析用カテーテル","37278000",0.180328,0.17437,0.631945,0.0262796,{"medical_device_id":129,"generic_name":130,"class_classification":75,"jmdn_code":131,"name_similarity":132,"definition_similarity":133,"vector_similarity":134,"score":135,"id":129,"category_code":92,"category_name":93,"subcategory_name":119,"data_exist":14,"product_count":36,"company_count":36,"market_size":36,"market_size_unit":36,"growth_ratio":36,"average_price":36,"average_price_unit":36,"domestic_ratio":36},691,"人工腎臓装置","34995000",0.325581,0.0647249,0.620061,0.016129,{"medical_device_id":137,"generic_name":138,"class_classification":42,"jmdn_code":139,"name_similarity":140,"definition_similarity":141,"vector_similarity":142,"score":143,"id":137,"category_code":92,"category_name":93,"subcategory_name":119,"data_exist":51,"product_count":144,"company_count":145,"market_size":146,"market_size_unit":55,"growth_ratio":147,"average_price":148,"average_price_unit":58,"domestic_ratio":35},2382,"透析用血液回路セット","34999102",0.285714,0.149184,0.601139,0.015873,17,12,245,-15.19,364,[150,156,163,170,177,184,190,196,202,207,213,218,223,227,233,239,243,247,252,257,263,267,271,276,280,284,289,293,297,301,305,309,313,317,321,325,329,333,338,342,346,350,354,358,362,366,370,374,378,382,385,388,391,395,398,401,405,409,414,417,421,424,428],{"product_code":151,"device_name":152,"device_class":8,"medical_specialty":10,"k510_count":153,"pma_count":35,"event_count":154,"recall_count":144,"device_name_ja":155},"KOC","Accessories, Blood Circuit, Hemodialysis",182,1219,"血液透析用血液回路アクセサリ",{"product_code":157,"device_name":158,"device_class":8,"medical_specialty":10,"k510_count":159,"pma_count":35,"event_count":160,"recall_count":161,"device_name_ja":162},"FJI","Dialyzer, Capillary, Hollow Fiber",131,8411,7,"中空糸型ダイアライザ",{"product_code":164,"device_name":165,"device_class":8,"medical_specialty":10,"k510_count":166,"pma_count":35,"event_count":167,"recall_count":168,"device_name_ja":169},"KPO","Dialysate Concentrate For Hemodialysis (Liquid Or Powder)",123,30004,106,"血液透析用透析液原液（液体又は粉末）",{"product_code":171,"device_name":172,"device_class":8,"medical_specialty":10,"k510_count":173,"pma_count":35,"event_count":174,"recall_count":175,"device_name_ja":176},"FJK","Set, Tubing, Blood, With And Without Anti-Regurgitation Valve",77,7980,35,"逆流防止弁付き／なし血液用チューブセット",{"product_code":178,"device_name":179,"device_class":8,"medical_specialty":10,"k510_count":180,"pma_count":35,"event_count":181,"recall_count":182,"device_name_ja":183},"FKQ","System, Dialysate Delivery, Central Multiple Patient",61,19,2,"中央多人数用透析液供給システム",{"product_code":185,"device_name":186,"device_class":8,"medical_specialty":10,"k510_count":187,"pma_count":35,"event_count":188,"recall_count":71,"device_name_ja":189},"LIF","Dialyzer Reprocessing System",57,116,"透析器再処理装置",{"product_code":191,"device_name":192,"device_class":8,"medical_specialty":10,"k510_count":193,"pma_count":35,"event_count":194,"recall_count":145,"device_name_ja":195},"FKP","System, Dialysate Delivery, Single Patient",50,1065,"単一患者用透析液供給システム",{"product_code":197,"device_name":198,"device_class":8,"medical_specialty":10,"k510_count":199,"pma_count":35,"event_count":200,"recall_count":35,"device_name_ja":201},"FJG","Dialyzer, Parallel Flow",36,101,"平行流型透析器",{"product_code":203,"device_name":204,"device_class":8,"medical_specialty":10,"k510_count":175,"pma_count":35,"event_count":205,"recall_count":35,"device_name_ja":206},"FIB","Protector, Transducer, Dialysis",41,"透析用トランスデューサ保護具",{"product_code":208,"device_name":209,"device_class":8,"medical_specialty":10,"k510_count":210,"pma_count":35,"event_count":211,"recall_count":52,"device_name_ja":212},"FIN","Tank, Holding, Dialysis",18,5,"透析用貯留タンク",{"product_code":214,"device_name":215,"device_class":8,"medical_specialty":10,"k510_count":210,"pma_count":35,"event_count":216,"recall_count":71,"device_name_ja":217},"MQS","System, Hemodialysis, Access Recirculation Monitoring",271,"血液透析アクセス再循環モニタリング装置",{"product_code":219,"device_name":220,"device_class":8,"medical_specialty":10,"k510_count":221,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":222},"FIZ","Meter, Conductivity, Non-Remote",13,"非遠隔式電気伝導度計",{"product_code":224,"device_name":225,"device_class":8,"medical_specialty":10,"k510_count":145,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":226},"FHS","Dialyzer, Single Coil","シングルコイル型透析器",{"product_code":228,"device_name":229,"device_class":8,"medical_specialty":10,"k510_count":145,"pma_count":35,"event_count":230,"recall_count":231,"device_name_ja":232},"FKR","Subsystem, Proportioning",20,10,"比例混合サブシステム",{"product_code":234,"device_name":235,"device_class":8,"medical_specialty":10,"k510_count":236,"pma_count":35,"event_count":237,"recall_count":35,"device_name_ja":238},"FIL","System, Dialysate Delivery, Single Pass",8,58,"シングルパス型透析液供給装置",{"product_code":240,"device_name":241,"device_class":8,"medical_specialty":10,"k510_count":236,"pma_count":35,"event_count":53,"recall_count":182,"device_name_ja":242},"FKH","Solution-Test Standard-Conductivity, Dialysis","透析用標準導電率試験液",{"product_code":244,"device_name":245,"device_class":8,"medical_specialty":10,"k510_count":161,"pma_count":35,"event_count":161,"recall_count":53,"device_name_ja":246},"FIR","Pump, Blood, Extra-Luminal","管外式血液ポンプ",{"product_code":248,"device_name":249,"device_class":8,"medical_specialty":10,"k510_count":161,"pma_count":35,"event_count":250,"recall_count":182,"device_name_ja":251},"MSE","Hemodialyzer, Re-Use, Low Flux",53,"再使用型低フラックス人工腎臓（透析器）",{"product_code":253,"device_name":254,"device_class":8,"medical_specialty":10,"k510_count":255,"pma_count":35,"event_count":211,"recall_count":35,"device_name_ja":256},"FIF","Set, Dialysis, Single Needle With Uni-Directional Pump",6,"単方向ポンプ付き単針透析用セット",{"product_code":258,"device_name":259,"device_class":260,"medical_specialty":10,"k510_count":255,"pma_count":35,"event_count":71,"recall_count":261,"device_name_ja":262},"FKG","Tray, Start\u002FStop (Including Contents), Dialysis","1",11,"透析用開始・終了トレイ（内容物含む）",{"product_code":264,"device_name":265,"device_class":8,"medical_specialty":10,"k510_count":255,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":266},"FLB","Meter, Conductivity, Induction, Remote Type","遠隔式誘導伝導度メーター",{"product_code":268,"device_name":269,"device_class":8,"medical_specialty":10,"k510_count":255,"pma_count":35,"event_count":35,"recall_count":71,"device_name_ja":270},"MNV","Strip, Dialysate Ph Indicator","透析液pH指示試験紙",{"product_code":272,"device_name":273,"device_class":8,"medical_specialty":10,"k510_count":211,"pma_count":35,"event_count":274,"recall_count":35,"device_name_ja":275},"FIH","Pump, Infusion Or Syringe, Extra-Luminal",139,"管腔外用注入ポンプ・シリンジポンプ",{"product_code":277,"device_name":278,"device_class":8,"medical_specialty":10,"k510_count":211,"pma_count":35,"event_count":71,"recall_count":35,"device_name_ja":279},"FJF","Detector, Air Bubble","気泡検出器",{"product_code":281,"device_name":282,"device_class":8,"medical_specialty":10,"k510_count":211,"pma_count":35,"event_count":236,"recall_count":35,"device_name_ja":283},"FJT","Intracatheter, Dialysis","透析用イントラカテーテル",{"product_code":285,"device_name":286,"device_class":8,"medical_specialty":10,"k510_count":211,"pma_count":35,"event_count":287,"recall_count":35,"device_name_ja":288},"FKJ","Filter, Blood, Dialysis",172,"血液透析用フィルタ",{"product_code":290,"device_name":291,"device_class":8,"medical_specialty":10,"k510_count":52,"pma_count":35,"event_count":53,"recall_count":35,"device_name_ja":292},"FIG","Clamp, Tubing, Blood, Automatic","自動血液チューブ用クランプ",{"product_code":294,"device_name":295,"device_class":8,"medical_specialty":10,"k510_count":52,"pma_count":35,"event_count":261,"recall_count":35,"device_name_ja":296},"FJD","Detector, Leak, Blood","血液漏検出器",{"product_code":298,"device_name":299,"device_class":8,"medical_specialty":10,"k510_count":52,"pma_count":35,"event_count":231,"recall_count":35,"device_name_ja":300},"FKY","Connector, Tubing, Dialysate","透析液チューブ用コネクタ",{"product_code":302,"device_name":303,"device_class":8,"medical_specialty":10,"k510_count":52,"pma_count":35,"event_count":161,"recall_count":35,"device_name_ja":304},"FLC","Station, Dialysis Control, Negative Pressure Type","陰圧型透析制御装置",{"product_code":306,"device_name":307,"device_class":8,"medical_specialty":10,"k510_count":52,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":308},"KXM","System Accessories, Extracorporeal","体外循環システム附属品",{"product_code":310,"device_name":311,"device_class":8,"medical_specialty":10,"k510_count":52,"pma_count":35,"event_count":145,"recall_count":71,"device_name_ja":312},"ODX","Autonomous Extracorporeal Blood Leak Detector\u002FAlarm","自律型体外循環血液漏出検知器／アラーム",{"product_code":314,"device_name":315,"device_class":8,"medical_specialty":10,"k510_count":53,"pma_count":35,"event_count":211,"recall_count":35,"device_name_ja":316},"FID","Tubing, Dialysate","透析液チューブ",{"product_code":318,"device_name":319,"device_class":8,"medical_specialty":10,"k510_count":53,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":320},"FJB","Detector, Dialysate Level","透析液レベル検出器",{"product_code":322,"device_name":323,"device_class":8,"medical_specialty":10,"k510_count":53,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":324},"FJZ","Declotting Tray, Kit (Including Contents)","血栓除去用トレイ・キット（内容物含む）",{"product_code":326,"device_name":327,"device_class":8,"medical_specialty":10,"k510_count":53,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":328},"FKI","Set, Dialyzer Holder","ダイアライザホルダーセット",{"product_code":330,"device_name":331,"device_class":8,"medical_specialty":10,"k510_count":53,"pma_count":35,"event_count":71,"recall_count":35,"device_name_ja":332},"FLA","Monitor, Temperature, Dialysis","透析用温度モニタ",{"product_code":334,"device_name":335,"device_class":8,"medical_specialty":10,"k510_count":182,"pma_count":35,"event_count":336,"recall_count":71,"device_name_ja":337},"FKB","Connector, Blood Tubing, Infusion T",30,"輸液用血液回路コネクタ（T字型）",{"product_code":339,"device_name":340,"device_class":8,"medical_specialty":10,"k510_count":182,"pma_count":35,"event_count":52,"recall_count":71,"device_name_ja":341},"LLB","System, Blood, Extracorporeal And Accessories","体外循環血液システム及び付属品",{"product_code":343,"device_name":344,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":345},"FIJ","System, Dialysate Delivery, Recirculating, Single Pass","透析液供給装置（再循環式・単回通過式）",{"product_code":347,"device_name":348,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":349},"FIW","Alarm, Pillow Pressure","枕圧式アラーム",{"product_code":351,"device_name":352,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":71,"recall_count":35,"device_name_ja":353},"FJC","Detector, Blood Level","血液検出器",{"product_code":355,"device_name":356,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":182,"recall_count":35,"device_name_ja":357},"FKD","Canister, Coil","コイル用キャニスター",{"product_code":359,"device_name":360,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":361},"FKL","Insert, Pump, Blood","血液ポンプ用インサート",{"product_code":363,"device_name":364,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":182,"recall_count":35,"device_name_ja":365},"KQQ","Tubing, Dialysate (And Connector)","透析液チューブ（コネクタ付き）",{"product_code":367,"device_name":368,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":369},"LRI","Ph Meter For Dialysis Hydrogen Ion Concentration","透析用pHメータ",{"product_code":371,"device_name":372,"device_class":8,"medical_specialty":10,"k510_count":71,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":373},"NTZ","Strip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator","透析液成分検査用試験紙（pH・重炭酸塩・ブドウ糖・酸）",{"product_code":375,"device_name":376,"device_class":260,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":221,"recall_count":35,"device_name_ja":377},"FIA","Chair, Dialysis, Unpowered, Without Scales","非電動式透析用椅子（秤機能なし）",{"product_code":379,"device_name":380,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":71,"device_name_ja":381},"FIK","System, Dialysate Delivery, Recirculating","循環型透析液供給システム",{"product_code":383,"device_name":384,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"FIS","Flowmeter, Dialysate",{"product_code":386,"device_name":387,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"FJA","Manometer, Water",{"product_code":389,"device_name":390,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"FJJ","Dialyzer, Twin Coil",{"product_code":392,"device_name":393,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":52,"recall_count":71,"device_name_ja":394},"FJP","Adaptor, Y","Y字アダプタ",{"product_code":396,"device_name":397,"device_class":260,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"FKE","Tie, Dialysis",{"product_code":399,"device_name":400,"device_class":260,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"FKF","Gun, Tie, Dialysis",{"product_code":402,"device_name":403,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":182,"recall_count":35,"device_name_ja":404},"FKM","Adaptor, Fistula","瘻孔用アダプタ",{"product_code":406,"device_name":407,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":71,"recall_count":35,"device_name_ja":408},"KQR","Detector, Air Or Foam","空気・泡検出器",{"product_code":410,"device_name":411,"device_class":260,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":412,"recall_count":35,"device_name_ja":413},"MON","System, Hemodialysis, Remote Accessories",78,"血液透析用遠隔操作アクセサリ",{"product_code":415,"device_name":416,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"NNG","Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed",{"product_code":418,"device_name":419,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":211,"device_name_ja":420},"PEV","Dialysis Administration Kit","透析投与キット",{"product_code":422,"device_name":423,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":35,"recall_count":35,"device_name_ja":36},"PPH","Single Needle With Uni-Directional Pump Kit",{"product_code":425,"device_name":426,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":53,"recall_count":35,"device_name_ja":427},"PPL","Single Needle (Co-Axial Flow) Dialysis Kit","シングルニードル(同軸フロー)透析キット",{"product_code":429,"device_name":430,"device_class":8,"medical_specialty":10,"k510_count":35,"pma_count":35,"event_count":71,"recall_count":35,"device_name_ja":431},"PRO","Anti-Regurgitation Blood Tubing Kit","逆流防止血液チューブキット",{"510k":433,"classification":434,"enforcement":435,"event":436,"event_backfill":437,"pma":438,"warning_letter":439},"2026-09-07T05:11:19.067+00:00","2026-09-07T05:11:15.53+00:00","2026-09-07T05:11:16.99+00:00","2026-09-08T04:01:01.362+00:00","2026-09-07T05:17:28.839+00:00","2026-09-07T05:11:20.665+00:00","2026-09-07T05:15:19.69+00:00",{"items":441,"total":35},[],{"items":443,"total":35},[],{"items":445,"total":35},[]]