SPEEDICATH FLEX CH12 MEN'S NELATON SELF-LUBRICATING CATHETER IMMERSED IN STERILE PHYSIOLOGICAL SOLUTION 30 PIECES

Disposable product.
Contains no natural rubber latex, PVC or phthalates.

CE Class (Directive 93/42/EEC): I sterile.

Standard
ISO 9001:2000, DS/EN ISO 9001:2000, ISO 13485:2003 and DS/EN ISO 13485:2003

Description
SpeediCath Flex is a flexible-bodied bladder catheter for intermittent catheterization.
Like the other devices in the SpeediCath range, it is self-lubricating, sterile and single-use.
The catheter is already immersed in sterile saline solution to activate the lubricating coating.
SpeediCath Flex is a catheter with a flexible tip that facilitates passage through the sphincter and urethra.
The catheter is entirely covered by a protective guide, which provides protection from possible external contamination during insertion (caused for example by contact with the user's hands or other external bodies).
Inside the primary packaging, SpeediCath Flex constitutes a closed system as the ends of the catheter are screwed together.
The lubricating liquid is inserted between the catheter and the protective guide, making it possible to manipulate the catheter without coming into contact with the liquid.
The catheter is equipped with a universal connector so it can be connected to a urine collection bag.
The primary packaging is designed to ensure maximum discretion and when closed forms a sterile barrier for the device.
After use, the catheter can be reinserted inside.

Catheter
The catheter body has beveled holes and a flexible tip to guide insertion into the urethra.

External grip and connector
The external grip and connector are welded to the protective guide that covers the catheter.
When the catheter is closed, the connector and grip are screwed together, ensuring that the lubricating fluid does not leak out.
During catheterization, the user can grasp the soft grip to slide the protective guide and insert the catheter.

Protective guidance
The translucent protective rail is soldered to the external connector and the turquoise socket.
The user can touch and grasp the protective guide without contaminating the catheter underneath.

Dimensions
Below are the overall dimensions of the opened product and catheter body when the protective guide is stacked at the end.

Exclusive Features
The SpeediCath line of catheters features internally lubricated and beveled holes.
This feature makes the catheter gentle on the urethral mucosa.
Furthermore, SpeediCath is the only self-lubricating catheter on the market already immersed in saline solution (European patent issued for Italy No. 935478).
This system is designed to speed up the preparation of the catheter (other catheters normally require several seconds to activate the lubricant) and to keep it lubricated for a long time.

SpeediCath Flex is a sterile, disposable, self-lubricating bladder catheter for intermittent catheterization.
The use of this catheter is indicated in cases of urinary retention.
The catheter is designed for connection to urine collection bags.
The catheter is particularly suitable for emptying the bladder in patients who are unable to urinate spontaneously.
Using SpeediCath Flex is simple, quick and atraumatic, making it suitable even for those who have a permanent need for this type of aid.

Contraindications and incompatibilities
Not indicated in those patients with a medical evaluation unsuitable for treatment.

Composition
The SpeediCath Flex catheter is made of PU (polyurethane) and has a hydrophilic PVP (polyvinylpyrrolidone) coating.
The liquid in which the catheter is immersed is 0.9% sterile saline solution, with the addition of 6% PVP.
The primary packaging of the catheter is made of a multilayer of PETP, Aluminum and Polyethylene.

Sterilization
The catheter is sterilized by electron beam irradiation.

Validity
2 years from date of manufacture.

Type	Code commercial	Measure	CND Code	Code ISO	Code GMDN	Code PARAF
SpeediCath Flex SpeediCath Flex SpeediCath Flex SpeediCath Flex	28920 28922 28924 28916	CH 10 CH 12 CH 14 CH 16	U01010501 U01010501 U01010501 U01010501	09.24.06.012 09.24.06.012 09.24.06.012 09.24.06.012	45603 45603 45603 45603	970928166 970928178 970928180 970928141

Packaging
Unit of use: 1 catheter enclosed in a sealed, sterile container.
Order unit: 30 units of use in a cardboard box containing instructions for use in Italian.
Packaging: 3 order units in cardboard box.

Product storage
SpeediCath Flex should be stored in a dry place, at room temperature and away from direct sunlight.
However, exposure to extreme temperatures for up to 24 hours will not cause damage to the catheter.

Disposal
The product does not contain any ecotoxic components and therefore does not require special disposal procedures. Do not dispose of in the environment as it is not biodegradable.