Intended purpose of use: Indwelling catheter to drain urine from the urinary bladder. For use with adults for routine procedure and/of post operative care.
Product description:
Materials: Silicone-coated natural rubber latex. Shall be free from biological hazard when tested for biocompatibility.
Urethral catheter with balloon: Foley catheter 2-way with nelaton tip.
Central channel for urinary drainage, straight rounded distal end with lateral eyes (bladder side), proximal end with cup connector allowing catheter to be connected to urine bag.
Side channel for inflating balloon, ending by a non-return valve with Luer tip connector.
Diameter expressed in Charriere, French gauge.
Length expressed in cm.
Balloon capacity expressed in ml.
Colour code / external diameter visible on connector.
Size selected:
Diameter: CH14
Length: 30 - 40cm, external diameter 4.7 mm, green
Balloon capacity, 5-15ml: the amount of sterile water to be inserted into the balloon is usually printed on the side of the nozzle end.
5 ml for paediatric balloon
10 ml balloon for routine drainage
30 ml of larger balloons specifically for post-operative use
Single-use.
Sterile. Shelf life 3 years
Initial sterilisation method: ethylene oxide gas of equivalent
Instructions for use:
Sterile urethral catheter device designed to be introduced into the bladder cavity, to drain off urine, instil a liquid of irrigate the bladder.
If lubrication is necessary to help to introduce the catheter, the substance used must not cause physical of chemical alterations to thecatheter.
If necessary, use sterile water.
The balloon should be inflated with water of physiological saline.
The size has been chosen as being the most commonly used.
Safety process:
The urethral catheter is for SINGLE USE only.
When inserting a urethral catheter, use strict aseptic techniques.
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use
One (1) Foley catheter in an individual sterilised peel pack. One (1) box of 50 Foley catheters.
Labelling on the primary package shall be as per regulations applied to the device.
Symbols as per ISO 15223.
Secondary packaging: Protected unit.
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of EU Regulations 2017/745 (MDR) with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class IIa device
Safety & product Standards (all submissions must be as per the latest revision of standards):
Must comply with the following standards:
ISO 20696 Sterile urethral catheters for single use
ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISO 10993-1 Biological Evaluation of Medical Devices Part 1:Evaluation and Testing. You should select the tests appropriate for the duration and level of contact.
Environmental requirements:
ISO 14001
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.42 |
| Pack of 10 | $4.09 |
| Pack of 50 | $20.43 |
