Disposable Foley Catheter Kit(ISO Approved)Product Name: Disposable Foley Catheter Kit
Structure:Disposable foley catheter kit is consisted of foley catheter, urine bag, etc.
Number of Registered Certificate:15041892 001
Operative Standard:EN ISO 13485:2012+AC:2012, MDD 93/42/EEC Annex II
Expected Usage:Application for urination and rinsing the bladder by inserting into the bladder cavity through the urethra, it is suited to those enuresis patients, they can also sample for urine culture, etc.
Characteristics:The raw material of disposable foley catheter kit has no side effects to human body.
1) Use the unit following the common process of urethral catheterization.
2) It is only for one-off use, it must be destroyed after use.
3) Check whether the package is in good condition, or else it is strictly prohibited to use.
4) The product was sterilized by epoxy ethane and assures asepsis for two years.
5) Date of production was printed on the seal of the package, sterilization symbol and date of invalidation also can be found on the package.
6) It can only be used by medical staff or under the direction of medical staff.
7) The product is deposited under door temperature in dry condition.
8) If it is necessary to retain the catheter for long, it must be changed every week.
9) Urethras injured 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.
Individual disposable foley catheter is packed by PE packing, the middle and outer package is corrugated box.
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:Two years
Manufacturing Company:Changzhou Medical Bioengineering Co., Ltd
Address:Tianzhutang, Dongqing, Zhenglu Town, Wujin District, Changzhou City, 213114, China
EU Representative:Shanghai International Holding Corp. GmbH (Europe) JIN LIANG
Address:Eiffestrasse 80, 20537 Hamburg, Germany
|1000ml urine bag||Underpad|
|urine test tube||Fenestrated Drape|
|20cc syringe||Gauze Pads|
|Plastic Forceps||latex/PE gloves|
|PVPI Cotton Balls||Outer Tray|