CE/ISO Disposable Infusion Set
|Type ||infusion set |
|Certification ||CE, SGS ,ISO13485|
|Sterilization||Ethylene Oxide |
|Quality Guarantee Period ||3 years |
|Package ||PE or Blister |
|Specification ||CE , ISO , GMP |
|Tube material ||PVC/Non- PVC |
|Feature ||Disposable |
|Needle ||with and without needle |
|stype ||Luer Slip or Luer lock |
|Tube length ||1.5m or OEM |
|Components ||Plastic Spike |
|Air vent ||With / without air vent |
|Filter ||with / without filter|
1. Intravenous cannula: Made of Stainless steel AISI 304, diameter and Length according to the ISO standards. Listed in the table.
2. Cannula Protector: Made of Medical grade PE,
3. Double wings: Made of medical PVC, injection plastic, soft enough, Coloured according to the AS 2485 Standards.
4. Soft tube: Made of transparent medical grade PVC, soft enough, 30cm, 60cm, 90cm, 100cm in length, outer diameter 2.50mm, inner
5. Luer lock connector: Made of transparent, hard PVC.
6. Luer lock Cover: Made of transparent PVC. With thread. Mechanically
7. Cannula is assembled with wings together mechanically.
8. Tube and wings, tube and connector is glued with solvent Cyclohexanone.
9. Blister: Medical grade gelatinized paper(dialyse paper), plastic film.
1. Sterilized by EOG, single use, non-toxic, non pyrogenic
2. The cannula with triple sharpening, it's polished, this makes
3. The soft wings permit an easy grip making the fixing easy.
4. Colour codes to identify the diameter of the cannula (diameter of the
Cannula indicated on the wings)
1. Polybag individual packing, 100PCS/box, 2000PCS/CTN
2. Blister packing, 100PCS/box, 2000PCS/CTN
About usJiangsu Jichun Medical Devices Co., Ltd. was established in 1988 (with the original name Zhenglu Medical Materials Factory), is located in fertile Yangtze River Delta of Changzhou City, with the provincial road 232 passing by the gate of the company, with convenient transportation and advantageous environment. In 2008 in order to enlarge production scale, the company began land acquisition in Zhenglu industrial development zone and built the new plants, now covers a total area of 36, 000 square meters, with building area of 18, 000 square meters and class 100, 000 cleaning workshop area of 5, 500 square meters.
|with different model||can be OEM requirement||100,000pcs |
The company mainly deals with the development, production and marketing of the medical polymer medical devices for single use. The production capacity of the main products is: 1, 000 million sets of injection needles per year, 600 million sets of syringes per year and 100 million sets of infusion devices per year. The company is with beautiful surroundings, advanced equipments, well-equipped facilities, and all kinds of advanced product measuring instruments and scientific test methods. The "Jichun" brand products produced in the company sell well worldwide, to Europe, America and Southeast Asia. Customers have high opinion of the quality and the service, with the cooperating partners and sales volum continuously increasing.
The company has a period of more than twenty years development history, with the distinctive human and geographic advantages that Changzhou is the old empire city and the location in Shanghai and Nanjing special economic zone, develops its own specialties in the aspects of injection molding, automatic assembly and packaging. The company has engaged senior top management, recruited lots of technicians, and established a complete set of quality management system. According to the requirements of ISO 13485: 2003/YY/T0287-2003 Medical devices_Quality management system_Requirements for Regulatory Purposes, Medical devices good manufacturing practice (try out), Medical devices good manufacturing practice Sterile medical devices implementation principles and inspection and evaluation standards (try out), US21 CFR Part 820 Medical devices current good manufacturing practice (cGMP), RDC59 Medical devices good manufacturing practice (GMP) and MDD 93/42/EEC Medical devices directive, assure the implementation and operation of the quality management system in the company.
In 2001 the company was appraised "credible production of quality labeled enterprise" by Chinese Association for Medical Devices Industry, Chinese Nursing Association and Chinese Fundation for Customer Protection. In 2002 the company passed ISO9002 and CE Certification, and in 2004, passed the ISO9001/ISO13485 and CE Certification. We have pioneered a developing road dominant by the precise manufacture of medical devices for single use.
In the new century, Jichun people will base on the market, look to the future, keep striving and forge ahead. We will seek the development of the company by the innovation of the concept, technology and system, to contribute to the human health.