[product name] shell polysaccharide sheath.
[specification model] pure cotton, nonwovens.
[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 20182140542.
[structure and composition] the shell polysaccharide is mainly composed of cotton swabs, chitosan dressing, umbilical cord, umbilical cord, medical adhesive tape and medical adhesive plaster.
[product performance] : 1. the appearance of the umbilicus bag should be soft, without damage or disconnection, and the parts should be free of stains, odors and clean surfaces. 2. protection of umbilical cord: of the method of spunlace nonwovens used in breaking strength should accord with standard of fz/t64012.2-2001 in 3.3 to the relevant provisions of the class b, the pure cotton cloth used exert 30 n tensile fracture, protect the umbilical cord of saturated water quantity should be no less than 8 times of its weight. the formaldehyde content of cotton cloth is less than 20 mg/kg. the ph value of cotton cloth is 4.0 ~ 7.5; 3. the static tension of the umbilical cord was not broken. 4. the medical rubber ring stretches itself twice without breaking. 5. chitosan dressing shall meet the requirements of yzb/ yu0214-2014 standard or provide supplier qualification, inspection report and supply contract. 6, glue stick a sticky according to appendix b yy/t 0148-0148 test, within the oven during the test, stick on the stainless steel plate paste adhesive tape at the top of the slide should be no more than 2.5 ㎜. peel strength test according to appendix b yy/t 0148-0148, paste adhesive tape average force per 1 ㎝ width should be no less than 1.0 n; 4. the shell polysaccharide sheath should be sterile; 6. if the case of chitosan is sterilized by ethylene oxide, the residues of ethylene oxide should not be greater than 10 g/g; 7. the cytotoxicity should not be greater than 2 levels, and the skin stimulation ph value 0 ~ 0.4, should have no late hair hypersensitivity reaction.
【 applicable scope 】 for newborns to break the umbilical position protection.
contraindication: it is forbidden for people who are allergic to chitosan.
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 expiry date shall be seen in the packing seal, and the sterilization date shall be in the outer packing box. 3. this product is sterilized by ethylene oxide and is sterile for two years.
[use method] 1. open the package before use, and cover the umbilicus with the end of the shell polysaccharide dressing sheet on the baby's umbilical cord; 2. wrap the other end around the abdomen for a week and fasten the buckle or paste firmly. 3. it is recommended to replace it in 24 hours.
[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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