Single-use positive pressure intravenous indwelling needles
- Device class
- Class III
- Model specifications
- 型号:两通型(TZ-II.型)、三通型(TZ-III.型); 规格:0.6×16mm(26G×0.63IN)、0.6×19mm(26G×0.75IN)、0.75×16mm(24G×0.63IN)、0.75×19mm(24G×0.0.75IN)、0.9×19mm(22G×0.75IN)、0.9×25mm(22G×1.00IN)、1.1×25mm(20G×1.00IN)、1.1×30mm(20G×1.18IN)、1.1×40mm(20G×1.57IN)、1.1×48mm(20G×1.88IN)、1.3×30mm(18G×1.18IN)、1.3×40mm(18G×1.57IN)、1.3×48mm(18G×1.88IN).型号：两通型(TZ-Ⅱ型)、三通型(TZ-Ⅲ型)； 规格：0.6×16mm(26G×0.63IN)、0.6×19mm(26G×0.75IN)、0.75×16mm(24G×0.63IN)、0.75×19mm(24G×0.75IN)、0.9×19mm(22G×0.75IN)、0.9×25mm(22G×1.00IN)、1.1×25mm(20G×1.00IN)、1.1×30mm(20G×1.18IN)、1.1×40mm(20G×1.57IN)、1.1×48mm(20G×1.88IN)、1.3×30mm(18G×1.18IN)、1.3×40mm(18G×1.57IN)、1.3×48mm(18G×1.88IN)。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20233140516
- Approval date
- April 19, 2023
- Expiry date
- April 18, 2028
- Name
- Jiangxi HONGDA MEDICAL Equipment Group Ltd.江西洪达医疗器械集团有限公司
- Province/Region
- Jiangxi江西
- Address
- No. 39, Shengli South Road, Jinxian County, Nanchang City, Jiangxi Province江西省南昌市进贤县城胜利南路39号
- Production address
- 江西省南昌市进贤县城胜利南路39号
This product is used for intravenous indwelling continuous infusion of patients, and the indwelling time is not more than 72 hours.
本产品用于患者静脉留置连续输液，留置人体时间不大于72小时。
The product consists of protective sleeves, catheters, metal wedges, catheter holders, isolation plugs, syringes, needle holders, water stop clamps, extension tubes, positive pressure fittings (2-way and 3-way versions) and punctureable end caps. The catheter is made of polyurethane (PUR), the inner layer of the extension tube is made of thermoplastic polyurethane (TPU), and the outer layer is DEHP plasticized polyvinyl chloride material. The product is sterilized by ethylene oxide for single use.
产品由保护套、导管、金属楔、导管座、隔离塞、针管、针座、止水夹、延长管、正压接头(两通型和三通型)和可穿刺端帽组成。其中导管采用聚氨酯（PUR）材料，延长管内层采用热塑性聚氨酯（TPU）材料，外层为DEHP增塑的聚氯乙烯材料。产品经环氧乙烷灭菌，一次性使用。
- Remark
- ／
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Single-use positive pressure intravenous indwelling needles in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20233140516 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on April 19, 2023.
This page provides complete registration details including registrant information, province location (Jiangxi), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.