一次性使用真空靜脈血樣采集容器

廣西華度醫(yī)用器材有限公司

桂械注準20162220073

南寧市國凱大道89號8號廠房

2024-10-11

2026-05-10

產(chǎn)品由試管、膠塞、帽蓋及采血管內(nèi)的添加劑和附加物，試管是塑料(PET)/玻璃管。本品為無菌產(chǎn)品。

與一次性使用靜脈采血針配合使用，用于人體靜脈血的收集、運輸、儲存。

2024年10月11日 1、型號、規(guī)格由“檸檬酸鈉（1:4）2ml、3ml、5ml、檸檬酸鈉（1:9）：2ml、3ml、4ml、5ml、肝素鋰：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、肝素鈉：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、無添加劑 ：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、氟化鈉/EDTAK2：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、促凝劑/分離膠：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml、促凝劑：2ml、3ml、4ml、5ml、6ml、7ml、8ml、9ml、10ml”變更為“檸檬酸鈉（枸櫞酸鈉）（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；檸檬酸鈉（枸櫞酸鈉）（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；肝素鋰：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；肝素鈉：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；氟化鈉/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；促凝劑/分離膠：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；促凝劑：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；無添加劑：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；分離膠/肝素鋰：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；分離膠/肝素鈉：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、結(jié)構(gòu)及組成由“產(chǎn)品由容器、塞子及采血管內(nèi)的添加劑和附加物，容器是PET塑料容器。本品為無菌產(chǎn)品?！弊兏鼮椤爱a(chǎn)品由試管、膠塞、帽蓋及采血管內(nèi)的添加劑和附加物，試管是塑料（PET）/玻璃管。本品為無菌產(chǎn)品?！?；3、適用范圍由“與靜脈采血針配套使用，用于靜脈血樣標本的采集、轉(zhuǎn)運、預處理和保存?！弊兏鼮椤芭c一次性使用靜脈采血針配合使用，用于人體靜脈血的收集、運輸、儲存?！?；4、產(chǎn)品技術(shù)要求變更對比表詳見附件。

南寧市國凱大道89號8號廠房

檸檬酸鈉(枸櫞酸鈉)(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；檸檬酸鈉(枸櫞酸鈉)(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；肝素鋰：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；肝素鈉：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； 氟化鈉/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；促凝劑/分離膠：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；促凝劑：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；無添加劑：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；分離膠/肝素鋰：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；分離膠/肝素鈉：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個月

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