[product name] use the interventional blood contrast kit at one time.
[specification model] intervention type.
[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.]
[technical requirements no.]
[structure and composition] the product consists of basic configuration and optional configuration. basic configuration: medical absorbent gauze block, laparotomy single, disposable single, disposable use of treatment towel, disposable surgical clothing, disposable mask, disposable medical cloth; choose configuration: disposable dispensing with syringes, disposable sterilized rubber surgical gloves, medical absorbent gauze pad, medical cotton ball, sterile plastic handle knife, medical forceps, sponge brush, small bowl, square plate, medical cotton swabs, disposable hat, adhesive wound care stick, disposable medical cushion, medical asepsis shielding, hemostatic forceps, small pots, cups, cups, cups, disposable medical rubber examination gloves.
[product performance] 1. the package should be well sealed, with no gap, no puncture, and the contents should be neatly arranged; no damage, no stain or impurities should be found in all the parts of the radiography package. sewing parts should be sewn firmly, needle code even, flat, no crease, no jump needle, open line, leakage phenomenon. 2. the sewing needle distance of the sewing parts shall be no less than 8 needles within 3cm. 3. the appearance of the operating garment should be free of mildew, no damage, no stains and no impurities; the needle code should be uniform, straight, no crease, no jump needle, open line and leak. the hot pressing of the operating clothes should be uniform, straight, no wrinkle, no leakage pressure; the material of the chest film (if any) is coated nonwovens, plastic films or nonwovens, and the dimensions should not be less than 40cm x 60cm, and the tolerance: 10cm; if it is not less than 35g/m2, the film should be flat, free of bubbles and dissociation. if there is plastic film on the sleeve, the plastic film should not be damaged, and the thickness of plastic film should be no less than 0.01mm; plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm; the specification of non-woven fabric shall not be less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. the surgical sleeves should be no less than 35g/m2, and the film should be flat, free of bubbles and separated. there is plastic film in the sleeve, the plastic film should not be damaged, the thickness of plastic film should not be less than 0.01mm; (if any) the sewing or hot pressing should be firm, and the strength should be greater than 10n. the rupture strength of each belt and the joint of the operating garment should be greater than 10n. the performance of the operating garment should meet the standard performance requirements of yy/t0506; the suture line should not show strong blue fluorescence in the test a test in appendix d of yy 0594-2006 standard. the total amount of soluble in water should not exceed 0.50%. 4. the single specification should be no less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. 5. single use should be a qualified product for obtaining medical device registration certificate. 6. disposable therapeutic towels shall be qualified products to obtain registration certificate of medical devices. 7. the medical absorbent gauze piece shall be the qualified product for obtaining the medical device registration certificate. 8. disposable masks shall be qualified products for obtaining registration certificate of medical devices. 9. disposable medical package should not be less than 20g/m2; the longitudinal fracture strength of nonwoven fabric should be greater than or equal to 13n, and the transverse fracture strength should be greater than or equal to 8n. if the package is made of hot pressure, the hot pressing part should be firm and not cracked. 10. disposable syringes should be used as qualified products of medical device registration certificate. 11. disposable sterilized rubber surgical gloves shall be qualified products obtained from medical device registration certificate. 12. the medical absorbent gauze pad shall be the qualified product for obtaining the medical device registration certificate. 13. the medical cotton ball shall be a qualified product for obtaining the medical device registration certificate. 14. sterile plastic handle scalpel should be qualified products for obtaining medical device registration certificate. 15. the medical tweezers should be symmetrical, and the appearance should be smooth, without front edge, burr, crack, pitting and trachoma. tweezers should have good elasticity. 16. the adhesive force of sponge head and brush is not less than 10n, and its joints should not be loose. 17. the small bowl should be smooth, without burr or injection flow; 18. the square plate shall be smooth, without burr or injection flow. 19. medical cotton swabs shall be qualified products for obtaining the medical device registration certificate. 20. a disposable hat shall be a qualified product for obtaining a medical device registration certificate. 21. self-adhesive wound care should be a qualified product to obtain medical device registration certificate. 22. disposable medical mats shall be qualified products for obtaining registration certificate of medical devices. 23. the sterile protective cover shall be a qualified product for obtaining the medical device registration certificate. 24. hemostatic forceps shall be qualified products for obtaining registration certificate of medical devices. 25. the basin should be smooth and without burrs. 26. the measuring cup should be smooth and without burr; the scale should be clear and accurate. 27. the cup should be smooth and without burr; should be clean, smooth, no impurities, no holes. 2.28 the cup should be smooth and without burr; should be clean, smooth, no impurities, no holes. 29. disposable medical rubber inspection gloves shall be qualified products for obtaining medical device registration certificate. 30. the name, specification and quantity of the items in the package should meet the requirements of the interventional configuration list. the angiography package should be sterile. 32. the residual amount of epoxy ethane should not be greater than 10ug/g.
[scope of application] applicable to the clinical application of angiography in patients.
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.
3. this product is sterilized by ethylene oxide.
1. make sure the outer packing is in good condition and open the package.
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.
[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.
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