China NMPA legacy archive 国械注准20243141170Disposable Fine Filter Infusion Set
- Device class
- Class III
- Model specifications
- 输液器型号分为:SC1型(单穿刺自动排气型)、SC2型(单穿刺自动排气止液型)、DC1型(双穿刺自动排气型)、DC2型(双穿刺自动排气止液型). 根据产品配置不同,规格分为SC1-1,SC1-2,SC1-3,SC1-4,SC1-5,SC1-6,SC1-7,SC1-8,SC2-1,SC2-2,SC2-3,SC2-4,SC2-5,SC2-6,SC2-7,SC2-8,DC1-1,DC1-2,DC1-3,DC1-4,DC2-1,DC2-2,DC2-3,DC2-4. 若带防针刺静脉输液针,防针刺静脉输液针规格:0.45×13.5 RWLB、0.5×17.5 RWLB、0.55×17.5 RWLB、0.55×20 RWLB、0.6×19 TWLB、0.6×22.5 TWLB、0.7×19 TWLB、0.7×22.5 TWLB、0.8×19 TWLB、0.8×26 TWLB、0.9×19 TWLB、0.9×26 TWLB、1.2×19 TWLB、1.2×26 TWLB、1.2×38 TWSB. 药液过滤器规格为0.22μm、1.2μm、2.0μm、3.0μm、5.0μm.
- Approval department
- State Drug Administration
- Registration number
- 国械注准20243141170
- Approval date
- June 20, 2024
- Expiry date
- June 19, 2029
- Province/Region
- Shandong
- Address
- No. 1, Weigao Road, Weihai Torch High-tech Industrial Development Zone, Shandong Province
- Production address
- 山东省威海火炬高技术产业开发区威高路1-1 号
It is suitable for clinical intravenous infusion of drugs.
适用于临床静脉输注药物。
The product is composed of a cork trocar protective sleeve, a cork trocar, an air inlet with an air filter and a stopper, a liquid stop card, a drip bucket, a pipeline, a liquid medicine filter, a flow regulator, an injection piece, an outer cone joint, an outer cone joint protective sleeve, and an anti-needle puncture intravenous infusion needle, among which the stop card, the injection piece, the outer cone joint protective sleeve, and the anti-needle puncture intravenous infusion needle are optional. The raw material of the pipeline is TOTM plasticized PVC, and the raw materials of other components are described in the product technical requirements. The nominal pore sizes of the chemical liquid filter are 0.22 μm, 1.2 μm, 2.0 μm, 3.0 μm, and 5.0 μm. Single-use, ethylene oxide sterilization.
产品由瓶塞穿刺器保护套、瓶塞穿刺器、带空气过滤器和塞子的进气口、止液卡、滴斗、管路、药液过滤器、流量调节器、注射件、外圆锥接头、外圆锥接头保护套、防针刺静脉输液针组成，其中止液卡、注射件、外圆锥接头保护套、防针刺静脉输液针为选配。管路原材料为TOTM增塑的PVC，其他各组件的原材料见产品技术要求。药液过滤器标称孔径为0.22μm、1.2μm、2.0μm、3.0μm、5.0μm。一次性使用，环氧乙烷灭菌。
- Appendix
- 产品技术要求
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