[product name] disposable syringe for dispensing.
[specifications and models] are divided into two parts and three parts according to the structure, which are divided into middle head and partial head type; the capacity is divided into 10ml, 20ml, 30ml, 50ml and 100ml. the type of dispensing needle is divided into two types: side hole needle (cz) and inclined plane needle (xz). according to the thin wall (tw) and normal wall (rw); divided into φ according to diameter 0.9 mm, 1.2 mm and 1.4 mm φ φ, φ 1.6 mm, 1.8 mm and 2.1 mm φ φ, φ 2.4 mm, 2.7 mm and 3.0 mm φ φ, φ 3.4 mm.
[name of registrant] henan jianqi medical equipment co. ltd.
the dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
[after-sales service unit] henan jianqi medical equipment sales co., ltd.
[name of production enterprise] henan jianqi medical equipment co., ltd.
the dingluan industrial zone in changyuan county.
[production address] dingluan industrial zone, changyuan county.
[contact information] 0373-8690789.
[production license] the food and drug regulatory apparatus is permitted to be made in 20080036.
[registration certificate no.]yu ordnance mark 20182140496.
[structure and composition] consists of dispenser and dispensing needle. the dispenser is composed of ruler, zero scale line, dividing capacity line, nominal capacity scale line, overcoat edge, cone head, jacket, piston, core rod and pressing hand. the dispensing needle is composed of needle seat, needle tube and sheath.
[product performance] the outer taper joint of the cone head shall conform to the provisions of gb/t 1962.1-2001 or gb/t 1962-2001. 2. when the lateral hole needle tube is not greater than 100kpa, the flow rate should not be less than the same diameter and length and the minimum inner diameter of the needle tube under the same condition, the flow rate is 80%. 3. the pollution index of side hole needle should not exceed 90. 4. there should be more than 3 cuttings produced by each puncture 100 times. 5. the axial static tension specified in table 1 shall be applied at the joint of the needle tube and the needle seat, which shall continue for 15s. neither shall be loose or separated. 6. no corrosion marks shall be found in the area where the needle is soaked. the taper joint of the 7 pin seat shall conform to the provisions of gb/t 1962.1-2001 or gb/t 1962-2001. 8. there should be no leakage during the contact between the coat and the piston. in the negative pressure test, the contact part of the coat and the piston shall not produce a leakage phenomenon, and the piston and the core rod shall not be separated. 9. the maximum permissible tolerance of the dispenser is equal to or greater than half of the nominal capacity, which should conform to the relevant provisions in table 1. 10. the liquid volume of the dispenser in the coat shall not exceed the regulation of table 1. 11. the total content of lead, zinc, tin and iron should be no more than 5 mu g/ml, and the content of cadmium should be less than 0.1g /ml. 12. the ph value of the dispenser extract was not more than 1.0 when compared with the same batch blank control solution. 13. the difference in the consumption of potassium permanganate solution of 0.002mol/l should be 0.5ml compared with the same batch blank control liquid phase of the dispenser and the equivalent volume. 14. the dispenser is sterilized by ethylene oxide, and the residual amount of ethylene oxide is not greater than 10 mu g/g. 15. the dispenser is sterile.
[scope of application] for clinical extraction, dissolution and preparation of liquid medicine.
contraindication: no contraindications.
1. this product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use.
2. the production batch number and the expiry date can be seen in the packing seal or certificate, and the sterilization date is in the outer packing box.
3. this product is sterilized by ethylene oxide and is sterile for two years.
4. no body injection.
5. that is, it should not be retained and destroyed after use.
6. do not use hand or unsterilized items to contact with the liquid or dispensing needle.
7. when the side hole needle is used, the diluent should be pumped several times to ensure that all the liquid is used in the patient, and it is recommended to use the bevel needle for the preparation of trace drugs.
8. it is not suitable for pharmaceutical instructions that the polyolefin plastic injection equipment should not be used.
9. careful use of polyolefin plastic and stainless steel materials.
[use method] 1. remove the product from the small package, and connect the syringe head with the required standard dispensing needle;
2. remove the protective sleeve of the dispensing needle and insert the injection needle into the drug;
3. remove the core rod, and take the medicine liquid into the inside of the dispensing syringe;
4. drain the inner air of the syringe and carry out the liquid medicine;
5. after the dispensing is completed, the product is placed in the designated recovery position and processed uniformly.
[storage method] 1. this product is used in the carriage and hold of the cabins, and is kept clean, without pressure, sunshine and rain and snow.
2. handle gently in handling and avoid violent collision;
3. the product shall be stored away from the fire source, and the relative humidity shall not exceed 80%, without corrosive gas and well-ventilated and clean environment.
[production date] see the packing seal.
expiry date: see the packing seal.
[label, package logo]
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