| 产品名称 | 一次性使用湿化吸氧管 |
|---|---|
| 结构及组成/主要组成成分 | 一次性使用湿化吸氧管由吸氧管、氧气湿化瓶和连接接头组成，其中吸氧管和氧气湿化瓶为必配件，连接接头为选配件，不同型号的吸氧管及氧气湿化瓶供选配。该产品以无菌状态提供，氧气湿化瓶采用无菌灌装生产工艺，吸氧管、连接接头经环氧乙烷灭菌，一次性使用。 |
| 适用范围/预期用途 | 本产品用于吸氧时氧源与吸氧者之间的氧气直接输送或湿化后输送。 |
| 型号规格 | I-1-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-1-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-2-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-2-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-3-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-3-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-1-S-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-2-S-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-2-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-2-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-3-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-3-2-100/120/150/180/200/220/260/280/300/340/500/650A /B |
| 产品储存条件及有效期 | 不适用 |
| 注册证编号 | 苏械注准20242080357 |
| 注册人名称 | 南通安缇生物科技有限公司 |
| 注册人住所 | 南通市海门区临江镇临江大道188号D4幢101室 |
| 生产地址 | 南通市海门区临江镇临江大道188号D4幢三楼和四楼 |
| 备注 | 本文件与“苏械注准20242080357”医疗器械注册证共同使用 |
| 批准日期 | 2024-10-15 |
| 有效期至 | 2029-03-12 |
| 变更情况 | 2024-10-15型号、规格变更 由“Ⅰ-1-1-100/200/340/500/650、Ⅰ-1-2-100/200/340/500/650、Ⅰ-2-1-100/200/340/500/650、Ⅰ-2-2-100/200/340/500/650、Ⅰ-3-1-100/200/340/500/650、Ⅰ-3-2-100/200/340/500/650、Ⅱ-1-1-100/200/340/500/650、Ⅱ-1-2-100/200/340/500/650、Ⅱ-1-2-S-100/200/340/500/650、Ⅱ-2-1-100/200/340/500/650、Ⅱ-2-2-100/200/340/500/650、Ⅱ-3-1-100/200/340/500/650、Ⅱ-3-2-100/200/340/500/650”变更为“I-1-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-1-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-2-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-2-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-3-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、I-3-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-1-S-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-1-2-S-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-2-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-2-2-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-3-1-100/120/150/180/200/220/260/280/300/340/500/650A /B、II-3-2-100/120/150/180/200/220/260/280/300/340/500/650A /B”产品技术要求变更 由“技术要求变更情况对比表原条款及内容”变更为“技术要求变更情况对比表修改后条款及内容” |
| 编码代号2018 | 暂无权限 |
| 管理分类 | 暂无权限 |
| 企业联系电话 | 暂无权限 |
| 指导原则 | 暂无权限 |
| 共性问题 | 暂无权限 |
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