[product name] disposable sterile catheter package.
[specification and model] model: single cavity, double cavity and three cavity; Specifications: Fr6, Fr8, Fr10, Fr12, Fr14, Fr16, Fr18, Fr20, Fr22, Fr24, Fr26, Fr28, Fr30;
[name of registrant] henan jianqi medical equipment co. LTD.
The dingluan industrial zone in changyuan county.
[contact number] 0373-8690789.
湖北11选5开奖[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 note 20172660081.
[technical requirements no.] yu ordnance note 20172660081.
[structure and composition] the product consists of basic configuration and optional configuration. Basic configuration: the disposable use asepsis catheter, disposable drainage bag, medical forceps, medical cotton ball and selecting configuration: disposable medical rubber examination gloves, iodine volts cotton ball, paraffin tampon, medical absorbent gauze, disposable towels, items, boxes, cloth, sterile water tube, one-time use of dispensing, sponge brush with a syringe, disposable sterilized rubber surgical gloves, PE examination gloves.
1. The catheter package should be well sealed, with no gaps and no holes; All accessories in the catheter should be free of damage, no stain, no impurities. 2. Disposable sterilized catheter, tip, balloon and eyelet should be free of foreign matter; The external diameter of the catheter should be accurate to 0.01mm and its tolerance should be plus or minus 0.33mm. The balloon volume should be expressed in mL; The minimum length (L) and minimum length of pipe length (S) shall be specified in table 1 (see figure 1); The tapered and tapered interfaces should be integrated with the pipe body and should not be broken. The discharge conical interface should not be separated from the test connector; The balloon should have no leakage and should not affect the drain hole; The recovery rate of water shall not be lower than the value specified in table d. 2 of appendix D in accordance with appendix D test of YY0325-2002. Flow should be in accordance with table 2. 3. Disposable drainage bags shall be qualified products for obtaining medical device registration certificate. 4. The tweezers should be symmetrical, and the surface should be smooth, without front edge, burr, crack, pitting and trachoma. Tweezers should have good elasticity; The two pieces of tweezers should be strong enough to withstand the tension of 15N without breaking. The teeth should be clear and complete, should not be missing teeth, bad teeth defects; The guiding pin and positioning pin of tweezers should be firmly fixed. When the tweezers are open and closed, they should be flexible and should not be jammed. The handle of the tweezers should be clear and complete. There should be no flowers or flowers. 5. The medical cotton ball shall be the qualified product for obtaining the medical device registration certificate. 6. Disposable rubber inspection gloves shall be qualified products for obtaining medical device registration certificate. 7. Qualified products shall be obtained for medical device registration certificate. 8. The iodophor should be a qualified product for obtaining the medical device registration certificate. 9. The paraffin cotton ball shall be a qualified product for obtaining the medical device registration certificate. 10. The medical absorbent gauze piece shall be the qualified product for obtaining the medical device registration certificate. 11. One-time use of the hole towel shall be a qualified product for obtaining the medical device registration certificate. 12. The appearance of object box is smooth, without burr or obvious deformation; Thickness should not be less than 0.01mm. 13. The longitudinal fracture strength should be greater than or equal to 13N, and the transverse fracture strength should be greater than or equal to 8N. The cloth surface should be clean and clean, and the cut should be neat and free of edges. The specification of non-woven fabric is not less than 20g/m2. 14. The sterilization water is 10ml/ branch, which is in accordance with the provisions of the second part of the 2010 edition of the pharmacopoeia of the People's Republic of China. 15. Disposable syringes should be used as qualified products for obtaining registration certificate of medical devices. 16. The adhesive force of sponge head and brush is not less than 10N, and its joints should not be loose. 17. Disposable sterilized rubber surgical gloves shall be qualified products for obtaining registration certificate of medical devices. 18. PE inspection gloves shall be qualified products obtained from medical device registration certificate. 19. The catheterization package should be sterile; 20. The catheter is sterilized by ethylene oxide, and the residual amount of ethylene oxide should not be greater than 10ug/g.
[scope of application] applicable to clinical application of urinary catheterization.
Contraindication: no absolute contraindication.
1。 This product is a disposable product, which is damaged in packaging and is strictly prohibited to be used and destroyed after use。
2. See packaging seal or label on the production batch number, and the sterilization date is in the outer packing box.
湖北11选5开奖3. This product is sterilized by ethylene oxide.
1。 Make sure the outer packing is in good condition and open the package。
湖北11选5开奖2. Remove the inner parts according to the requirements.
3。 After the product is finished, it should be treated with medical waste to avoid pollution。
湖北11选5开奖[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 packaging seal or label.
Expiry date: see packaging seal or label.
[label, package logo]
[specification preparation date] February 7, 2017.