I. Product Name: Embryo Transfer Catheter
II. Product Model and Specification: None
III. Company Name: Shandong Weigao Group Medical Polymer Products Company Limited
IV. Registered Address: No.312, Shichang Avenue, Weihai City, Shandong Province, China
V. Manufacturing Address: No.312, Shichang Avenue, Weihai City, Shandong Province, China
VII. p>六、负责人：赵恒坤
七、售后服务机构：
山东威高集团医用高分子制品股份有限公司市场部
八、生产企业许可证号：鲁食药监械生产许 20060166号(补)
九、产品注册号：鲁食药监械（准）字2008第2660034号
Ten, product standard number:
YZB / Lu -2005 "embryo transfer catheter"
Xi, the main structure of the product, performance:
1, structure: embryo transfer catheter by the embryo transfer catheter tube, embryo transfer catheter outer tube, the inner cone connector, the sheath composition.
2, performance: our brand embryo transfer catheter, using medical grade polymer materials in the GMP standard requirements of 100,000 purification workshop, according to YZB / Lu -2005 "embryo transplantation catheter" requirements of the organization of production, in accordance with the "aseptic medical device production management norms" for management, in order to ensure the safety and effectiveness of the product. The products are sterilized by ethylene oxide, and the package is well sealed.
The main performance indexes are as follows:
(1) The product is sterile, and the sterile validity period is three years;
(2) The product shall have no skin irritation reaction;
(3) The product shall have no skin sensitization reaction;
(4) The product shall have no acute systemic toxicity;
(5) The product shall have no cytotoxicity;
(6) The product shall have No hemolytic reaction;
(7) Other technical indexes are in line with YZB/Lu -2005 "Embryo Transfer Catheter".
XII. Scope of application of the product:
It is suitable for intrauterine transfer of embryos.
Thirteen, contraindications:
People suffering from acute inflammation of the systemic and reproductive system.
Fourteenth, precautions, warnings and suggestive instructions:
1, disposable use, destroyed after use;
2, open the package, use immediately;
3, has been sterilized, the package is broken, prohibit the use of;
4, found in the package of foreign objects prohibit the use of;
5, the operation of prohibited by hand or unsterilized items It is prohibited to touch the catheter part with hands or unsterilized objects during operation.
Fifteen, labeling, labeling graphics, symbols and abbreviations: 2 STERILE EO 1, indicating that the ethylene oxide sterilization products.
2, single-use, indicating that the product can not be reused.
XVI, installation instructions: not applicable.
XVII, instructions for use:
1, open the package of the outer tube of the embryo transfer catheter, and extend the outer tube into the uterine orifice through the woman's vagina;
2, open the package of the inner tube of the embryo transfer catheter, and connect the conical connector of the inner tube to a syringe;
3, point the tip of the inner tube to the culture fluid in the petri dish, and pull the push rod of the syringe to attract a section of fluid;
4. Aim the tip of the inner tube at the selected embryo in the petri dish and pull the syringe to attract the embryo;
5. Stretch the inner tube into the woman's uterus through the inner lumen of the outer tube and push the syringe pusher to push the embryo as well as the liquid into the uterus so that it will be attached to the uterine wall;
6. After the operation is completed , remove the inner and outer catheters;
7. Examine the inner catheter to check whether there is any embryo residue.
Eighteen, maintenance methods: not applicable.
Nineteen, storage conditions, methods:
Twenty, validity period: three years.
xi. Other contents: none