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一次性使用真空靜脈血樣采集容器

國(guó)產(chǎn) 有效注冊(cè) Ⅱ

產(chǎn)品名稱：

一次性使用真空靜脈血樣采集容器

注冊(cè)人名稱：

廣西華度醫(yī)用器材有限公司

注冊(cè)(備案)號(hào)：

桂械注準(zhǔn)20162220073

注冊(cè)人住所：

南寧市國(guó)凱大道89號(hào)8號(hào)廠房

批準(zhǔn)(備案)日期：

2024-10-11

有效期至：

2026-05-10

結(jié)構(gòu)及組成：

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。

適用范圍：

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(yùn)輸、儲(chǔ)存。

代理公司：

代理公司地址：

變更情況：

2024年10月11日 1、型號(hào)、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。”變更為“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。”；3、適用范圍由“與靜脈采血針配套使用，用于靜脈血樣標(biāo)本的采集、轉(zhuǎn)運(yùn)、預(yù)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(yùn)輸、儲(chǔ)存?！?；4、產(chǎn)品技術(shù)要求變更對(duì)比表詳見附件。

生產(chǎn)地址：

南寧市國(guó)凱大道89號(hào)8號(hào)廠房

型號(hào)規(guī)格：

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

產(chǎn)品儲(chǔ)存條件及有效期：

18個(gè)月

管理類別：

Ⅱ

備注：

掛網(wǎng)信息

數(shù)據(jù)來源	注冊(cè)備案名	注冊(cè)證編號(hào)	型號(hào)規(guī)格	掛網(wǎng)報(bào)價(jià)
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	2ml	1.0000
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	2ml	0.9300
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	3ml	1.0000
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	4ml	1.0000
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	3ml	0.9300
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	5ml	1.0000
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	4ml	0.9300
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	6ml	1.0000
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	7ml	1.0000
遼寧省醫(yī)用耗材限價(jià)掛網(wǎng)（2024年第四批）	一次性使用真空靜脈血樣采集容器	桂械注準(zhǔn)20162220073	8ml	1.0000

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一次性使用真空靜脈血樣采集容器