I. Product Name: Closed Trauma Negative Pressure Drainage Set
II. Model Specification: Type I (single channel) and Type II (multi-channel)
III. Company Name: Shandong Weigao Group Medical Polymer Products Co. No.312, Shichang Avenue, Weihai City
VI. Contact Person: Zhao Hengkun
VII. After-sales Service Organization:
Shandong Weigao Group Medical Polymer Products Company Limited, Marketing Department
VIII. Manufacturer License No.: Lu Food and Drug Administration Mechineer Production License No. 20060166 (Supplement)
IX. No. 2660280 (more)
Ten, the product standard number: YZB / Lu -2009 "closed trauma negative pressure drainage set"
Eleven, the main structure of the product, performance:
1, structure: closed trauma negative pressure drainage set by the drainage tube, medical patch, medical sponge or absorbent dressing, gauze block, oil gauze, suction connecting tube, trapezoidal connector, Y-type connector, clamps, drain tubes, medical sponges or absorbent dressing, gauze blocks, oil gauze, suction connecting tube, trapezoidal connector, Y-type connector, clamps, drain tubes and other materials. Y-type connector, clamp, water-blocking filter, negative pressure tank, sterilized water for injection (non-injection), three-way valve, fixed adhesive, scissors and other components.
2, performance: our company produces closed trauma negative pressure drainage set using medical grade polymer materials in the GMP specification requirements of the 100,000 purification workshop, according to YZB / Lu -2009 "closed trauma negative pressure drainage set" requirements of the organization of production, in accordance with the "aseptic medical device production management norms" for management, in order to ensure product safety, effectiveness. The skin contact parts are sterilized and the package is sealed.
The main performance indicators are as follows:
a, skin contact accessories should be sterile, non-allergenic, non-irritating;
b, other technical indicators in line with the YZB / LU -2009 "Closed Trauma Negative Pressure Drainage Set".
Thirteen, contraindications:
Active bleeding.
Fourteenth, precautions, warnings and suggestive instructions:
a) prohibit dragging and pulling the drainage tube during operation, so as not to cause air leakage or pull the drainage tube out of the medical patch;
b) when replacing the negative pressure canister, turn off the clamp first, and then pull out the catheter, to prevent the seepage from flowing back;
c) the product is prohibited from being used for clinical operations other than traumatic negative pressure drainage
d) Disposable, destroy after use;e) Open the package and use immediately;
f) The main accessories have been sterilized, and the package is damaged, prohibit the use of;
g) The use of the package is prohibited when found foreign objects;
h) It can only be used for the clinical traumatic negative pressure drainage;
i) The accessories should be connected tightly to form an airtight system.
Fifteen, labeling, labeling graphics, symbols abbreviation:
No
Sixteen, installation instructions: not applicable