一次性使用真空静脉血样采集容器

一次性使用真空静脉血样采集容器

广西华度医用器材有限公司

桂械注准20162220073

南宁市国凯大道89号8号厂房

2024-10-11

2026-05-10

产品由试管、胶塞、帽盖及采血管内的添加剂和附加物，试管是塑料(PET)/玻璃管。本品为无菌产品。

与一次性使用静脉采血针配合使用，用于人体静脉血的收集、运输、储存。

2024年10月11日 1、型号、规格由“柠檬酸钠（1:4）2ml、3ml、5ml、柠檬酸钠（1:9）：2ml、3ml、4ml、5ml、肝素锂：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、肝素钠：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、EDTAK2 ：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、EDTAK3 ：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、无添加剂 ：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、氟化钠/EDTAK2：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、促凝剂/分离胶：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、促凝剂：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml”变更为“柠檬酸钠（枸橼酸钠）（1:4）：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、1.6ml、1.8ml、2ml、3ml、4ml、5ml；柠檬酸钠（枸橼酸钠）（1:9）：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml；肝素锂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；肝素钠：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；氟化钠/EDTA-K2：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；EDTA-K2：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、2.5ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；促凝剂/分离胶：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、；EDTA-K3：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；促凝剂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；无添加剂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、 真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；分离胶/肝素锂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；分离胶/肝素钠：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、 真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml”；2、结构及组成由“产品由容器、塞子及采血管内的添加剂和附加物，容器是PET塑料容器。本品为无菌产品。”变更为“产品由试管、胶塞、帽盖及采血管内的添加剂和附加物，试管是塑料（PET）/玻璃管。本品为无菌产品。”；3、适用范围由“与静脉采血针配套使用，用于静脉血样标本的采集、转运、预处理和保存。”变更为“与一次性使用静脉采血针配合使用，用于人体静脉血的收集、运输、储存。”；4、产品技术要求变更对比表详见附件。

南宁市国凯大道89号8号厂房

柠檬酸钠(枸橼酸钠)(1:4)：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、1.6ml、1.8ml、2ml、3ml、4ml、5ml；柠檬酸钠(枸橼酸钠)(1:9)：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml；肝素锂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；肝素钠：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml； 氟化钠/EDTA-K2：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；EDTA-K2：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、2.5ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；促凝剂/分离胶：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、；EDTA-K3：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；促凝剂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；无添加剂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、 真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；分离胶/肝素锂：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml；分离胶/肝素钠：非真空：0.1ml、0.2ml、0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、 真空：0.3ml、0.4ml、0.5ml、0.6ml、0.7ml、0.8ml、0.9ml、2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml

18个月

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