[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PXJ":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":127,"syncDates":171},{"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":38,"updated_at":39,"recall_count":40,"latest_recall_date":41,"k510_count":40,"pma_count":40,"event_count":42},4031,"PXJ","Umbilical Catheter Insertion Tray","2","880.5200","HO","General Hospital","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":35,"device_class":8,"implant_flag":36,"product_code":6,"review_panel":10,"gmp_exempt_flag":36,"third_party_flag":36,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":35,"life_sustain_support_flag":36,"medical_specialty_description":11,"summary_malfunction_reporting":37},{"fei_number":17,"registration_number":30},[18,19,20,21,22,23,24,25,26,27,28,29],"3004111573","3002902735","1000160458","1643817","1000512168","3014257280","3001236905","3007329020","3009888344","3035642068","1047429","1030451",[18,31,21,23,25,32,26,27,28,33,29,34],"1423537","2029015","9616088","1061124","","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",0,null,6,[],[45,54,63,71,79,87,95,102,110,118],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},1985,"泌尿器用カテーテル挿入・採尿キット","Ⅱ","14292000",0.396552,0.134503,0.66497,0.0327869,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},37,"末梢静脈挿入式中心静脈用カテーテルイントロデューサキット","Ⅳ","16615120",0.31746,0.121387,0.646675,0.0279734,{"medical_device_id":64,"generic_name":65,"class_classification":48,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},1986,"間欠泌尿器用カテーテルイントロデューサキット","16321000",0.283333,0.120944,0.653649,0.0267483,{"medical_device_id":72,"generic_name":73,"class_classification":48,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},1988,"泌尿器用カテーテルイントロデューサキット","32030000",0.3,0.144654,0.637813,0.0266667,{"medical_device_id":80,"generic_name":81,"class_classification":48,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},2106,"マニピュレーション・インジェクション子宮カテーテル","33911010",0.272727,0.174242,0.628902,0.0235816,{"medical_device_id":88,"generic_name":89,"class_classification":57,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},35,"末梢静脈挿入式中心静脈用カテーテル","36257100",0.381818,0.146341,0.586494,0.016129,{"medical_device_id":96,"generic_name":97,"class_classification":48,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":94},2069,"腹腔胸腔用カテーテルイントロデューサキット","70316000",0.190476,0.0933735,0.664413,{"medical_device_id":103,"generic_name":104,"class_classification":48,"jmdn_code":105,"name_similarity":106,"definition_similarity":107,"vector_similarity":108,"score":109},2029,"静脈用カテーテルイントロデューサキット","12161102",0.269231,0.076412,0.661639,0.015873,{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":116,"vector_similarity":117,"score":109},3704,"精液注入用子宮カテーテル","Ⅰ","34077000",0.369565,0.0990712,0.582357,{"medical_device_id":119,"generic_name":120,"class_classification":121,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},823,"腹膜灌流用カテーテルイントロデューサキット","Ⅲ","16992000",0.196721,0.118211,0.656266,0.015625,[128,132,136,140,144,148,152,156,159,162,165,168],{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"FOZ","Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days",506,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"NGT","Saline, Vascular Access Flush",40,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"FOS","Catheter, Umbilical Artery",34,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"LRS","I.V. Start Kit",30,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"PND","Midline Catheter",13,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"NZW","Heparin, Vascular Access Flush",7,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"QTI","Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device",1,{"product_code":157,"device_name":158,"device_class":8,"k510_count":155},"SEF","Central Venous Catheter With Manual Insertion System",{"product_code":160,"device_name":161,"device_class":8,"k510_count":40},"NZX","Water, Vascular Access Flush",{"product_code":163,"device_name":164,"device_class":8,"k510_count":40},"OWL","Peripheral Catheter Insertion Kit",{"product_code":166,"device_name":167,"device_class":8,"k510_count":40},"PEF","Heparin Flush In 0.45% Sodium Chloride",{"product_code":169,"device_name":170,"device_class":8,"k510_count":40},"PEZ","Central Venous Catheter Dressing Change Kit",{"510k":172,"classification":173,"enforcement":174,"event":175,"pma":176,"warning_letter":177},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]