Silicone Foley catheter valve are made out of Polypropylene Plastics, Stainless Steel Spring, Silicone rubber. The fitting area with the syringe having 6% luer taper is perfectly designed to suit the universal syringe tips.
Introduction :
Silicone Foley Catheter was developed for First time in INDIA by high profile technocrats with having sound knowledge and experience in all the disciplines of Medical Devices Manufacturing viz, Design & Development, Mass Production System, Total Quality Management, Sterilization, Biological standards and requirements etc,.
We help setting up projects as consultants and also offer turnkey projects for Silicone Foley Balloon Catheters. We design manufacture and supply entire range of machineries and tools for the Foley Balloon Catheters.
The products specification meets the requirements of Indian Standard and British Standards.
Manufacturing operations are carried out as per Good Manufacturing Practices (GMP). The safety requirements of the products are followed as per the established specifications and product compliance to such safety requirements are ascertained through series of Biological, Physical and functional tests.
The manufactured products are packed in a peel pack that has been qualified for sterile packing.
Thus packed products are sterilized by validated Ethylene Oxide Sterilization process.
Product Profile :
The product is made out of silicone material and no latex is involved and therefore biological reactivity is nil when compared with latex Foley Catheters.
This will eliminate the risk of irritation in the patient even when in condition of extended use.
The drainage lumen is bigger than standard latex Foley Catheters which has increased drainage flow.
Balloon integration with the catheter is done with a special process to eliminate rough edges.
Biological performance:
The Silicone Catheter was tested for its Biological response as per the International standard requirements and the product was proved non reactive.
Physical Performance :
Silicone Catheters were tested in house as per the Standard BS-1695 and the product passes all the performance test requirements.
Also the products were given to the leading urologists for their validation by using in the patients and the products performance was extremely satisfactory.
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