Disposable Precision Filter Light-Shielding Infusion Set with Needle
- Device class
- Class III
- Model specifications
- 型号规格:J-P型、J-P A型、J-P T型、J-P Z型、J-P AT型、J-P AZ型、J-P TZ型、J-P ATZ型、J-W型、J-W A型、J-W T型、J-W Z型、J-W AT型、J-W AZ型、J-W TZ型、J-W ATZ型,配套静脉输液针规格:0.45×13.5 RW LB、0.45×13.5 RW SB、0.45×19 RW LB、0.45×19 RW SB、0.5×19 RW SB、0.5×19 RW LB、0.55×19 RW LB、0.55×19 RW SB、0.6×19 TW SB、0.6×19 TW LB、0.6×24 TW LB、0.6×24 TW SB、0.7×19 TW LB、0.7×19 TW SB、0.7×24 TW SB、0.7×24 TW LB、0.8×19 TW SB、0.8×19 TW LB、0.8×26.5 TW LB、0.8×26.5 TW SB、0.9×19 TW SB、0.9×19 TW LB、0.9×26.5 TW SB、0.9×26.5 TW LB、1.2×19 TW LB、1.2×19 TW SB、1.2×26.5 TW LB、1.2×26.5 TW SB.型号规格：J-P型、J-P A型、J-P T型、J-P Z型、J-P AT型、J-P AZ型、J-P TZ型、J-P ATZ型、J-W型、J-W A型、J-W T型、J-W Z型、J-W AT型、J-W AZ型、J-W TZ型、J-W ATZ型，配套静脉输液针规格：0.45×13.5 RW LB、0.45×13.5 RW SB、0.45×19 RW LB、0.45×19 RW SB、0.5×19 RW SB、0.5×19 RW LB、0.55×19 RW LB、0.55×19 RW SB、0.6×19 TW SB、0.6×19 TW LB、0.6×24 TW LB、0.6×24 TW SB、0.7×19 TW LB、0.7×19 TW SB、0.7×24 TW SB、0.7×24 TW LB、0.8×19 TW SB、0.8×19 TW LB、0.8×26.5 TW LB、0.8×26.5 TW SB、0.9×19 TW SB、0.9×19 TW LB、0.9×26.5 TW SB、0.9×26.5 TW LB、1.2×19 TW LB、1.2×19 TW SB、1.2×26.5 TW LB、1.2×26.5 TW SB。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20233141674
- Approval date
- November 09, 2023
- Expiry date
- November 08, 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 has a light-avoiding range of 290nm~450nm, and is suitable for infusion of photosensitive drugs vincristine sulfate for injection, methotrexate for injection, levofloxacin hydrochloride injection, cisplatin for injection, cefmetazole sodium for injection, furosemide injection, nitroprusside sodium for injection.
本产品避光范围290nm～450nm，适用于输注光敏性药物注射用硫酸长春新碱、注射用甲氨蝶呤、盐酸左氧氟沙星注射液、注射用顺铂、注射用头孢美唑钠、呋塞米注射液、注射用硝普钠。
The disposable precision filter and light-proof infusion device with needle is composed of a bottle stopper trocar protective sleeve, a bottle stopper trox, an air intake device, a pipeline, a flow stop clip, a dropper bucket upper cover, a dropper, a drip bucket, a drip bucket lower cover, an ordinary flow regulator, a graduated flow regulator, an injection piece, an infusion patch (without medicine), a precision medicine liquid filter (1.2 μm, 2.0 μm, 3.0 μm, 5.0 μm), an outer cone connector, and an intravenous infusion needle. Among them, stop clips, injection parts, infusion patches (without medicine), and intravenous infusion needles are optional accessories. The product is sterilized by ethylene oxide, sterile and pyrogen-free. Single-use.
一次性使用精密过滤避光输液器 带针由瓶塞穿刺器保护套、瓶塞穿刺器、进气器件、管路、止流夹、滴斗上盖、滴管、滴斗、滴斗下盖、普通流量调节器、刻度流量调节器、注射件、输液贴（不含药）、精密药液过滤器（1.2μm、2.0μm、3.0μm、5.0μm）、外圆锥接头、静脉输液针组成。其中止流夹、注射件、输液贴（不含药）、静脉输液针为可选配件。产品经环氧乙烷灭菌，无菌、无热原。一次性使用。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Disposable Precision Filter Light-Shielding Infusion Set with Needle 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20233141674 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on November 09, 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.