




【产品名称】医用止血敷料
【规格型号】0.5g、1g、2g、3g、4g、5g、6g、7g、8g、9g、10g。
【结构组成】由壳聚糖、羧甲基壳聚糖粉末组成,装于聚乙烯瓶中。该产品以无菌状态提供,经辐照灭菌,一次性使用。
【适用范围】用于非慢性创面护理、止血,浅表创面使用,不用于体内。
【使用说明】创面经清创后,取本品均匀地撒在创面上,视创面大小增加用量。如需要,可以用绷带包扎或敷上无菌敷贴等。
【禁忌症】对壳聚糖过敏者慎用。
【灭菌方式】本产品采用辐照灭菌。
【贮藏】通风干燥处常温保存,避免阳光直射。
【警示】严格遵守医疗废弃物处理的现行规范和医院规定。
【注意事项】
1、本品已经无菌处理,开启后一次使用。若包装破损请勿使用;
2、本品仅适用于体表创面,禁止遗留于体内;
3、若出现创面感染,请医务人员及时处理;
4、若本品干结于创面,可用无菌水或生理盐水浸润后清除,避免二次损伤;
5、产品使用前应先进行创面的清创消毒,以防创面感染。对于紧急情况下未能清创消毒的创面,使用本产品止血后,应及时进行创面消毒,更换敷料,避免创面感染。
【生产日期】见标签。
【使用期限】二年
【医疗器械注册证编号】皖械注准20262140078
【产品技术要求编号】皖械注准20262140078
【生产许可证编号】皖药监械生产许20180040号
【注册人/生产企业/售后服务单位】安徽徽科生物工程技术有限公司
【注册人/生产企业住所】安徽省太和县经济开发区A区
【电话】0558-8215588
全国统一咨询电话:4008887208

PRODUCT INSTRUCTIONS FOR USE
【Product Name】 Medical Hemostatic Dressing
【Specification and Model】 0.5g, 1g. 2g. 3g, 4g. 5g. 6g. 7g. 8g, 9g, and 10g
【Structure and Compostion】 This product consists of chitosan and carboxymethyl chitosan powder,contained in a polyethyene bottle. This product is suppllied sterlle, sterlized by iradiation, andintended for single use only.
【intended Use】 This product is intended for use in non?chronic wound care and hemostasis. It isindicated for superficial wounds and is not intended for interal use.【instructions for Use】 After wound debridement, evenly sprinile the product over the wound surface.Adjust the amount according to the wound size. If necessary, the wound can be covered with abandage or sterile dressing.
【Contraindications】 Use with caution in individuals allergic to chitosan.
【Sterilization Method】This product is sterilized by inradiation.
【Storage】 Store at room temperature in a well-ventlated, dy place, protected from direct sunlight,
【Warming]】 Strictly comply with current regulations and hospital requirements for the disposal ofmedical waste.
【Precautions】
1. This product s suppled sterile and intended for single use Immedlately upon opening. Do not useif the package is damaged.
2. This product is for use on superficial wounds only. Do not leave in the body.
3. In case of wound infection, seek prompt medical attention from a healthcare professional.
4. If this product dries and adheres to the wound. t can be removed after soaking wth sterile wateror saline to avoid secondary injury.
5. The wound should be debrided and disinfected before use to prevent infection. For wounds thatcould not be debrided and disinfected in emergency situations, disinfect the wound and replacethe dressing promptly to avold infection after hemostasis is achieved with this product.
【Manufacturing Date】 See label.【Shelf Life】Two yearsI
【Medical Device Registration Certificate No.】 Anhul Medical Device Registration No.20262140078
【Product Techrical Specification No.】Anhul Medical Device Registration No.20262140078
【Production License No.】 Anhul Medica Device Production License No.20180040
【Registrant/Manufacturer/After-Sales Service Unit】Anhul Huike Bloengineering Technology Co., Ltd.
【Address of Registrant/Manufacturer】 Area A, Economic Development Zone, Taihe County, AnhulProvince
【Contact Information of Registrant/Manufacturer】Tel: 0558-8215588 Postal code: 236600
【Revision Date of Instructions for Use】 March 23, 2026
版权所有 安徽徽科生物工程技术有限公司 © 2009 - 2022 AHHUIKE Inc. 皖ICP备09010236号-1
公司生产地址:安徽省太和县经济开发区A区 电话:0558—8215588 传真:0558-8696288 技术支持:智盛源