【 product name 】 use change medicine bag at once.
[specification model] type I (suture type) type II (change 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.] yu ordnance note 20172640080.
[technical requirements no.]
[structure and composition] the product consists of basic configuration and optional configuration. Type I (suture type) by the basic configuration: medical absorbent gauze pieces, medical cotton ball, medical forceps, disposable medical cloth bags, trays and use configuration: scissors, disposable towels, disposable medical rubber examination gloves, non absorbable surgical sutures, medical suture needle, sterile plastic handle knife, adhesive wound paste composition, disposable sterilized rubber surgical gloves. Type II (dressing) from the basic configuration: medical forceps, medical absorbent gauze piece, iodine volts cotton ball, tray and choose configuration: disposable medical rubber examination gloves, disposable medical cloth, medical cotton ball, disposable towels, disposable towels, disposable use of single and small bowl, disposable sterilized rubber surgical gloves.
[product performance] 1。 The accessories should be clean, free of damage and impurities; The package should be well sealed, with no gaps and no holes。 2。 When using absorbent cotton gauze, the medical absorbent gauze should meet the requirements of the identification test A, B and C; In the case of cotton viscose blended gauze, cotton fiber should meet the requirements of the identification test A and C; The viscose fiber should meet the requirements of identification test B; The luster of the product shall meet the requirements of the identification test D; The solution should not be pink; Foreign fibers only allow occasionally a small amount of isolated foreign fibers; Fluorescent cotton and viscose gauze should meet its requirements; The number of yarn counts per 100mm shall be in accordance with the requirements set out in table 1 and table 2 of YY 0331-2006。 The quality of each square metre per square metre (in grams) should meet the requirements of YY 0331-2006 standard table 1 and table 2。 The minimum breaking force per 50mm (in newtons) should meet the requirements of YY 0331-2006。 The subsidence time should not exceed 10S; The total amount of soluble substance in ether is less than 0。50%; The surface active substance foam should not exceed 2mm。 The total amount of soluble in water soluble in water should not be greater than 0。50%; Starch and lacustrine solution should not appear blue, purple, light red or light brown; The colour of the liquid obtained by the leachable coloring matter should not be darker than the control liquid specified in appendix A。 The quality loss should not be greater than 8。0%。 The quality loss of cotton viscose blended yarn should not be greater than 11。0%; The total amount of sulphate ash sulphate ash should meet the requirements of table 3 of YY 0331-2006。 X-ray detectable components (if any) X-ray detectable components shall be not less than 55% of barium sulfate content of material or other have the same X-ray permeability of the material, the material should not fall off fiber, should not affect the softness of dressing or provides the raw material inspection report; The X-ray detectable component is gently drawn from the gauze block and its quality should meet the following requirements: single wire: not less than 0。5 g/m; Multifilament: no less than 0。28 g/m; The imaging of the standard samples should be significantly lighter than the background。 3。 The medical cotton ball shall be a qualified product for obtaining the medical device registration certificate。 4。 The tweezers should be symmetrical, and the appearance 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 non-woven booker should not be less than 20g/m2; 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; If the package is made of hot pressure, the hot pressing part should be firm and not cracked。 6。 The pallet appearance is smooth, without burr and injection flow; Thickness should not be less than 0。01mm。 7。 The scissors should be clean and sharp, and the combined force of the air shear should not be greater than 6。5N。 8。 One-time use of the hole towel shall be a qualified product for obtaining the medical device registration certificate。 9。 Disposable rubber inspection gloves shall be qualified products for obtaining medical device registration certificate。 10。 Non-absorbable surgical sutures shall be qualified products for obtaining registration certificate of medical devices。 11。 The medical suture needle shall be a qualified product for obtaining the medical device registration certificate。 12。 Sterile plastic handle scalpel should be qualified products to obtain medical device registration certificate。 13。 Self-adhesive wound care should be qualified products with medical device registration certificate。 14。 Disposable sterilized rubber surgical gloves shall be qualified products obtained from medical device registration certificate。 15。 The iodophor should be a qualified product to obtain the medical device registration certificate。 16。 Disposable therapeutic towels shall be qualified products to obtain registration certificate of medical devices。 17。 Single use should be a qualified product for obtaining medical device registration certificate。 18。 Small bowl appearance with smooth, no burr, injection flow; Thickness shall not be less than 0。1mm。 19。 The replacement cup shall be a qualified product with the medical device registration certificate。 20。 The name, specification and quantity of the items in the dressing package shall meet the requirements of table 1 and table 2。 21。 The replacement bag should be sterile。 22。 The residual amount of epoxy ethane should not be greater than 10ug/g。
[scope of application] applicable to medical institutions in the clinical treatment of patients with a change or suture。
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.