Audited Supplier
AS-E
Surgical Supplies Materials
CHANGSHENG
Blister Pack
ISO/CE, 14G; 16g; 18g
China
9018907000
Product Description
Simple Epidural Kit (AS-E) CE mark
Product Name:Disposable Epidural Anesthesia Puncture Kit
Structure:Disposable epidural anesthesia puncture kit is consisted of epidural anesthesia needle, liquid medicine filter, connector, epidural anesthesia catheter, etc.
Specification:AS-E
Number of Production Licence:Number of Production Licence of Jiangsu FDA is 2010-3660095.
Number of Registered Certificate:15041892 001
Operative Standard:EN ISO 13485:2012+AC:2012, MDD 93/42/EEC Annex II
Expected Usage:Application for epidural anesthesia puncture and drugs injection in operation room and emergency.
Characteristics:The raw material of disposable epidural anesthesia puncture kit has no side effects to human body.
Using Instructions
1) Use as conventional epidural anesthesia operation.
2) It is only for single use, and must be destroyed after use.
3) The product was sterilized by epoxy ethane gas and was valid for three years.
4) Check whether the package is in good condition, or else it is strictly prohibited to use.
5) Date of manufacture was printed on the seal of the individual package, sterilization symbol, Lot number and expiry date also can be found on the package.
6) The product is stored under door temperature and avoiding sunshine.
7) Those people who have spinal deformity, spinal tuberculosis or infections on the anesthesia part are strictly prohibited to use the product.
Points of Attention
1) The product is prohibited to use when the package is broken.
2) The product is prohibited to use when it exceed the valid date.
3) The product is sterilized and discard for single use, repeat use is prohibited.
4) The operation doctor should be trained.
Package
Individual disposable epidural anesthesia puncture kit is packed by blister packing, the middle and outer package is corrugated box.
Storage
The products should be stored in less than 80% relative humidity, non-corrosive gases and well-ventilated room.
Description of Label
1.For single use
2.The product is EO sterilized
Sterile Model:EO sterilization
Validated period of Sterilization: Three years
Manufacturing Company: Changzhou Medical Bioengineering Co., Ltd
Address: Tianzhutang, Dongqing, Zhenglu Town, Wujin District, Changzhou City, 213114, China
Post Code:213114
Tel: 86-519-88966750
Fax: 86-519-88964890
Website: andrew43.en.made-in-china.com
EU Representative:Shanghai International Holding Corp. GmbH (Europe) JIN LIANG
Address: Eiffestrasse 80, 20537 Hamburg, Germany
