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北京汉佰瀚医疗器械有限公司

境内医疗器械(注册) — “京械注准20152220784”基本信息
注册证编号京械注准20152220784 [查看相关产品信息]
注册人名称北京汉佰瀚医疗器械有限公司[查看公司信息]
注册人住所北京市通州区恒业八街6号院18号1至4层101
生产地址北京市通州区恒业八街6号院18号1至4层101
产品名称一次性使用真空静脉血样采集容器
管理类别第二类
型号规格促凝剂:HBH510C,HBH515C,HBH520C,HBH525C,HBH530C,HBH535C,HBH540C,HBH545C,HBH550C,HBH750C,HBH755C,HBH760C,HBH765C,HBH770C,HBH1070C,HBH1075C,HBH1080C,HBH1085C,HBH1090C,HBH1095C,HBH10100C;促凝剂+分离胶:HBH510CG,HBH515CG,HBH520CG,HBH525CG,HBH530CG,HBH535CG,HBH540CG,HBH740CG,HBH745CG,HBH750CG,HBH755CG,HBH760CG,HBH1060CG,HBH1065CG,HBH1070CG,HBH1075CG,HBH1080CG,HBH1085CG,HBH1090CG;氟化钠+草酸钾:HBH510SFP,HBH515SFP,HBH520SFP,HBH525SFP,HBH530SFP,HBH535SFP,HBH540SFP,HBH545SFP,HBH550SFP,HBH750SFP,HBH755SFP,HBH760SFP,HBH765SFP,HBH770SFP,HBH1070SFP,HBH1075SFP,HBH1080SFP,HBH1085SFP,HBH1090SFP,HBH1095SFP,HBH10100SFP;氟化钠+肝素锂:HBH510SFL,HBH515SFL,HBH520SFL,HBH525SFL,HBH530SFL,HBH535SFL,HBH540SFL,HBH545SFL,HBH550SFL,HBH750SFL,HBH755SFL,HBH760SFL,HBH765SFL,HBH770SFL,HBH1070SFL,HBH1075SFL,HBH1080SFL,HBH1085SFL,HBH1090SFL,HBH1095SFL,HBH10100SFL;氟化钠+肝素钠:HBH510SFH,HBH515SFH,HBH520SFH,HBH525SFH,HBH530SFH,HBH535SFH,HBH540SFH,HBH545SFH,HBH550SFH,HBH750SFH,HBH755SFH,HBH760SFH,HBH765SFH,HBH770SFH,HBH1070SFH,HBH1075SFH,HBH1080SFH,HBH1085SFH,HBH1090SFH,HBH1095SFH,HBH10100SFH;肝素钠:HBH510SH,HBH515SH,HBH520SH,HBH525SH,HBH530SH,HBH535SH,HBH540SH,HBH545SH,HBH550SH,HBH750SH,HBH755SH,HBH760SH,HBH765SH,HBH770SH,HBH1070SH,HBH1075SH,HBH1080SH,HBH1085SH,HBH1090SH,HBH1095SH,HBH10100SH;肝素锂:HBH510LH,HBH515LH,HBH520LH,HBH525LH,HBH530LH,HBH535LH,HBH540LH,HBH545LH,HBH550LH,HBH750LH,HBH755LH,HBH760LH,HBH765LH,HBH770LH,HBH1070LH,HBH1075LH,HBH1080LH,HBH1085LH,HBH1090LH,HBH1095LH,HBH10100LH;EDTA-K2:HBH510EK,HBH515EK,HBH520EK,HBH525EK,HBH530EK,HBH535EK,HBH540EK,HBH545EK,HBH550EK,HBH750EK,HBH755EK,HBH760EK,HBH765EK,HBH770EK,HBH1070EK,HBH1075EK,HBH1080EK,HBH1085EK,HBH1090EK,HBH1095EK,HBH10100EK;EDTA-K3:HBH510EK3,HBH515EK3,HBH520EK3,HBH525EK3,HBH530EK3,HBH535EK3,HBH540EK3,HBH545EK3,HBH550EK3,HBH750EK3,HBH755EK3,HBH760EK3,HBH765EK3,HBH770EK3,HBH1070EK3,HBH1075EK3,HBH1080EK3,HBH1085EK3,HBH1090EK3,HBH1095EK3,HBH10100EK3;EDTA-Na2:HBH510ENA,HBH515ENA,HBH520ENA,HBH525ENA,HBH530ENA,HBH535ENA,HBH540ENA,HBH545ENA,HBH550ENA,HBH750ENA,HBH755ENA,HBH760ENA,HBH765ENA,HBH770ENA,HBH1070ENA,HBH1075ENA,HBH1080ENA,HBH1085ENA,HBH1090ENA,HBH1095ENA,HBH10100ENA;柠檬酸钠(9:1):HBH510SC2,HBH518SC2,HBH520SC2,HBH527SC2,HBH530SC2,HBH536SC2,HBH540SC2,HBH545SC2,HBH550SC2,HBH750SC2,HBH754SC2,HBH760SC2,HBH763SC2,HBH770SC2,HBH1070SC2,HBH1072SC2,HBH1080SC2,HBH1081SC2,HBH1090SC2,HBH10100SC2,HBH510SC8,HBH518SC8,HBH520SC8,HBH527SC8,HBH530SC8,HBH536SC8,HBH540SC8,HBH545SC8,HBH550SC8,HBH750SC8,HBH754SC8,HBH760SC8,HBH763SC8,HBH770SC8,HBH1070SC8,HBH1072SC8,HBH1080SC8,HBH1081SC8,HBH1090SC8,HBH10100SC8;柠檬酸钠(4:1):HBH510SR2,HBH516SR2,HBH520SR2,HBH524SR2,HBH530SR2,HBH532SR2,HBH540SR2,HBH550SR2,HBH740SR2,HBH748SR2,HBH750SR2,HBH756SR2,HBH760SR2,HBH770SR2,HBH1064SR2,HBH1070SR2,HBH1072SR2,HBH1080SR2,HBH1090SR2,HBH10100SR2,HBH510SR8,HBH516SR8,HBH520SR8,HBH524SR8,HBH530SR8,HBH532SR8,HBH540SR8,HBH550SR8,HBH740SR8,HBH748SR8,HBH750SR8,HBH756SR8,HBH760SR8,HBH770SR8,HBH1064SR8,HBH1070SR8,HBH1072SR8,HBH1080SR8,HBH1090SR8,HBH10100SR8;肝素钠+分离胶:HBH510SHG,HBH515SHG,HBH520SHG,HBH525SHG,HBH530SHG,HBH535SHG,HBH540SHG,HBH740SHG,HBH745SHG,HBH750SHG,HBH755SHG,HBH760SHG,HBH1060SHG,HBH1065SHG,HBH1070SHG,HBH1075SHG,HBH1080SHG,HBH1085SHG,HBH1090SHG;肝素锂+分离胶HBH510LHG,HBH515LHG,HBH520LHG,HBH525LHG,HBH530LHG,HBH535LHG,HBH540LHG,HBH740LHG,HBH745LHG,HBH750LHG,HBH755LHG,HBH760LHG,HBH1060LHG,HBH1065LHG,HBH1070LHG,HBH1075LHG,HBH1080LHG,HBH1085LHG,HBH1090LHG;无添加剂:HBH510NR,HBH515NR,HBH520NR,HBH525NR,HBH530NR,HBH535NR,HBH540NR,HBH545NR,HBH550NR,HBH750NR,HBH755NR,HBH760NR,HBH765NR,HBH770NR,HBH1070NR,HBH1075NR,HBH1080NR,HBH1085NR,HBH1090NR,HBH1095NR,HBH10100NR;柠檬酸钠(9:1)+分离胶:HBH510PRP,HBH515PRP,HBH520PRP,HBH525PRP,HBH530PRP,HBH535PRP,HBH540PRP,HBH740PRP,HBH745PRP,HBH750PRP,HBH755PRP,HBH760PRP,HBH1060PRP,HBH1065PRP,HBH1070PRP,HBH1075PRP,HBH1080PRP,HBH1085PRP,HBH1090PRP;
结构及组成/主要组成成分Normal07.8磅02falsefalsefalseEN-USZH-CNX-NONE/*StyleDefinitions*/table.MsoNormalTable{mso-style-name:普通表格;mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0cm5.4pt0cm5.4pt;mso-para-margin:0cm;mso-para-margin-bottom:.0001pt;mso-pagination:widow-orphan;font-size:10.0pt;font-family:"TimesNewRoman",serif;}本产品由PET试管、胶塞、安全帽、标签和添加剂(添加剂的种类有EDTAK2,EDTAK3,EDTANa2,肝素钠,肝素锂,氟化钠,草酸钾,柠檬酸钠,促凝剂,也可以无添加剂)和附加物(有的种类的真空采血管需要附加分离胶)组成。
适用范围/预期用途Normal 0 7.8 磅 0 2 false false false EN-US ZH-CN X-NONE /* Style Definitions */ table.MsoNormalTable {mso-style-name:普通表格; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman",serif;} 本产品与一次性使用无菌静脉血样采集针配套使用,釆集静脉血样进行临床检验。
审批部门北京市药品监督管理局
批准日期2020/8/3
生效日期2020/8/3
有效期至2025/8/2
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