[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QMT":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":112,"syncDates":158},{"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":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":28,"pma_count":28,"event_count":26},6722,"QMT","Prep Kit – Vaccine Injection","2","880.5570","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 www.fda.gov\u002Fcdrh\u002Fode\u002Fconvkit.html.  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":21,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":22,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":21,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":23},{"fei_number":17,"registration_number":20},[18,19],"3005034064","3003911670",[18,19],"","N","Ineligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",1,"2021-07-28",0,[],[31,40,49,57,65,73,81,89,96,104],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":37,"vector_similarity":38,"score":39},3737,"喉頭注射キット","Ⅰ","33427000",0.378378,0.144737,0.661279,0.0322665,{"medical_device_id":41,"generic_name":42,"class_classification":43,"jmdn_code":44,"name_similarity":45,"definition_similarity":46,"vector_similarity":47,"score":48},1848,"医薬品・ワクチン注入用注射筒","Ⅱ","12132000",0.45,0.183529,0.623587,0.0304147,{"medical_device_id":50,"generic_name":51,"class_classification":43,"jmdn_code":52,"name_similarity":53,"definition_similarity":54,"vector_similarity":55,"score":56},2169,"点滴開始キット","33963000",0.210526,0.136213,0.649184,0.0280338,{"medical_device_id":58,"generic_name":59,"class_classification":43,"jmdn_code":60,"name_similarity":61,"definition_similarity":62,"vector_similarity":63,"score":64},2194,"ガス式針なし医薬品・ワクチン用注入器","42949000",0.26087,0.199541,0.611848,0.0278846,{"medical_device_id":66,"generic_name":67,"class_classification":43,"jmdn_code":68,"name_similarity":69,"definition_similarity":70,"vector_similarity":71,"score":72},2192,"医薬品・ワクチン用注入器","12504002",0.361702,0.154762,0.607327,0.0272529,{"medical_device_id":74,"generic_name":75,"class_classification":43,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},2193,"機械式針なし医薬品・ワクチン用注入器","18069000",0.24,0.199095,0.607715,0.0262575,{"medical_device_id":82,"generic_name":83,"class_classification":34,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},3855,"会陰洗浄キット","12996000",0.243902,0.116838,0.60781,0.0257937,{"medical_device_id":90,"generic_name":91,"class_classification":34,"jmdn_code":92,"name_similarity":53,"definition_similarity":93,"vector_similarity":94,"score":95},3850,"耳洗浄キット","11371000",0.100334,0.613968,0.0244813,{"medical_device_id":97,"generic_name":98,"class_classification":43,"jmdn_code":99,"name_similarity":100,"definition_similarity":101,"vector_similarity":102,"score":103},2310,"再使用可能な吸引キット","37447000",0.2,0.174419,0.607157,0.0231222,{"medical_device_id":105,"generic_name":106,"class_classification":43,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},1838,"医薬品・ワクチン注入用針","44127010",0.461538,0.195704,0.580623,0.0163934,[113,117,121,125,129,133,137,140,143,146,149,152,155],{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"FMI","Needle, Hypodermic, Single Lumen",691,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"MMK","Container, Sharps",114,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"SCL","Allergen And Vaccine Delivery Needles",25,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"PTI","Non-Coring (Huber) Needle",13,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"QNS","Low Dead Space Needle, Single Lumen, Hypodermic",3,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"MHC","Needle, Interosseous",2,{"product_code":138,"device_name":139,"device_class":8,"k510_count":136},"QYM","Ophthalmic Needle",{"product_code":141,"device_name":142,"device_class":8,"k510_count":26},"PVZ","Non-Stainless Steel Needle",{"product_code":144,"device_name":145,"device_class":8,"k510_count":28},"NKK","Needle, Hypodermic, Single Lumen, Reprocessed",{"product_code":147,"device_name":148,"device_class":8,"k510_count":28},"PWY","Lumbar Puncture Tray (Adult & Pediatric)",{"product_code":150,"device_name":151,"device_class":8,"k510_count":28},"PXB","Percutaneous Introducer Kit",{"product_code":153,"device_name":154,"device_class":8,"k510_count":28},"PXI","Thoracentesis Tray",{"product_code":156,"device_name":157,"device_class":8,"k510_count":28},"PXL","Venipuncture Kit",{"510k":159,"classification":160,"enforcement":161,"event":162,"pma":163,"warning_letter":164},"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"]