国械注准20233141395

Disposable Light-Shielded Infusion Set with Needle

一次性使用避光输液器 带针
Jiangxi HONGDA MEDICAL Equipment Group Ltd.·Class III·NMPA·Approved September 27, 2023
Device classification
Device class
Class III
Model specifications
P-P TYPE, P-P A TYPE, P-P T TYPE, P-P Z TYPE, P-P AT TYPE, P-P AZ TYPE, P-P TZ TYPE, P-P ATZ TYPE, P-W A, P-W A, P-W T, P-W Z, P-W AT, P-W AZ, P-W TZ, P-W ATZ TYPE, P-W ATZ TYPE; 1.2mm.
P-P型、P-P A型、P-P T型、P-P Z型、P-P AT型、P-P AZ型、P-P TZ型、P-P ATZ型、P-W型、P-W A型、P-W T型、P-W Z型、P-W AT型、P-W AZ型、P-W TZ型、P-W ATZ型;输液针规格按针管外径不同分为:0.45mm、0.5mm、0.55mm、0.6mm、0.7mm、0.8mm、0.9mm、1.2mm。
Approval department
State Drug Administration
国家药品监督管理局
Registration information
Registration number
国械注准20233141395
Approval date
September 27, 2023
Expiry date
September 26, 2028
Registrant
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 facility
Production address
江西省南昌市进贤县城胜利南路39号
Intended use
English

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.

中文

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。

Structure and composition
English

Disposable light-protected infusion device The needle is composed of a cork trocar protective sleeve, a cork trocar, an air intake device, a pipeline, a stop clamp, a drip bucket upper cap, a dropper, a drop hopper, a drop hopper, a general flow regulator, a scale flow regulator, an injection piece, an infusion patch (without medicine), a liquid filter (15μm), an external conical joint, and an intravenous infusion needle. Its stop-flow clip, injection parts, infusion stickers (without medicine), and intravenous infusion needles are optional accessories. The pipeline, drop bucket and intravenous infusion needle hose of this product are double-layer structure, the inner layer is TOTM plasticized polyvinyl chloride, the outer layer is DEHP plasticized light-protected polyvinyl chloride, the light-protecting agent is ferric oxide, and the raw materials of other components are detailed in the product technical requirements. The product is sterilized by ethylene oxide, sterile, pyrogen-free, single-use.

中文

一次性使用避光输液器 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)、药液过滤器(15μm)、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。本产品管路、滴斗及静脉输液针软管为双层结构,内层为TOTM增塑的聚氯乙烯,外层为DEHP增塑的避光聚氯乙烯,避光剂为三氧化二铁,其他组件原材料详见产品技术要求。产品经环氧乙烷灭菌,无菌、无热原,一次性使用。

Additional information
Appendix
产品技术要求
About this record

Access comprehensive regulatory information for Disposable Light-Shielded 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20233141395 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on September 27, 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.