河北康卫仕医疗科技有限公司
境内医疗器械(注册) — “冀械注准20202220473”基本信息
注册证编号 | 冀械注准20202220473 [查看相关产品信息] |
注册人名称 | 河北康卫仕医疗科技有限公司[查看公司信息] |
注册人住所 | 河北省石家庄市元氏县经济开发区诚信产业园益鑫路8号 |
生产地址 | 河北省石家庄市元氏县元氏大街95号 |
产品名称 | 一次性使用真空采血管 |
管理类别 | 第二类 |
型号规格 | 见产品概述 |
结构及组成/主要组成成分 | 无添加剂(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)促凝管(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)分离胶/促凝剂(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK2(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK3(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)肝素钠(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)肝素锂(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK2/分离胶(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)EDTAK2/氟化钠(0.5mL、1mL、1.5mL、2mL、2.5mL、3mL、3.5mL、4mL、4.5mL、5mL、5.5mL、6mL、6.5mL、7mL、8mL、9mL、10mL)枸橼酸钠1:4(0.5mL、1.28mL、1.6mL、2mL、2.4mL、3mL、3.2mL、4mL、5mL、6mL、7mL、8mL、9mL、10mL)枸橼酸钠1:9(0.5mL、1.8mL、2mL、2.7mL、3mL、3.6mL、4mL、4.5mL、5mL、6mL、7mL、8mL、9mL、10mL)本品由玻璃试管或PET、丁基胶塞、塑料帽盖、标签、添加剂(如有)及附加物(如有)组成。与采血针配套使用,分别用于临床人体静脉血液标本的采集、抗凝/促凝/分离/保存。分类编码:22-11-04 |
适用范围/预期用途 | 与采血针配套使用,分别用于临床人体静脉血液标本的采集、抗凝/促凝/分离/保存。 |
审批部门 | 河北省药品监督管理局 |
批准日期 | 2020/6/24 |
生效日期 | 2020/6/24 |
有效期至 | 2025/6/23 |