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1. Product description The product, a Specimen Collection Facilitator Device, is a plastic sleeve for the toilet seat used for diagnostic tests such as urine and stool tests. 2. What ColOff® is used for ColOff® is a disposable device that facilitates the stool and urine collection as well as for pregnancy tests in the physiological position (sitting on the toilet seat). 3. ColOff®’s attributes ColOff® is a patented, hygienic, disposable, inexpensive, comfortable (used in the physiological position), easy to use and user-friendly device for patients, increasing infection control whilst minimizing specimen contamination. 4. Before using ColOff® for Stool and urine collection or pregnancy test: Clean the toilet seat before starting the procedure. Your healthcare provider will give you a specimen container to use. If ColOff® is going to be used for a stool test, ensure that you have urinated so that you do not get any urine in the stool sample. Put on gloves before handling feces. Feces can contain germs that spread infection. 5. Warning ColOff® In case of possible danger, problem, or other unpleasant situation, adhere to the following: (a) Do not touch feces: it may be contaminated. (b) To avoid risk of suffocation, keep out of reach of children. Parent supervision is recommended when used by children. (c) The collected specimens must be sent to the testing laboratory as soon as possible and should be stored at 4°C until the specimens can be transported. Place the lid on the container and label it according to your healthcare provider. Wash your hands after you remove your gloves. 6. Composition and Information: Made from Braskem’s Green Plastic Film (HDPE - High Density Polyethylene - CAS: 9002-88-4). Inert and Non-toxic. Single use only. Non Sterile. 7. Storage Instructions: Store in a clean, cool, dry place below 30°C. 8. Product Register ColOff® is a IVD Medical Device: TGA - AUST R 219634 in Australia/New Zealand. Class 1 in-vitro medical diagnostic device in U.S. (FDA). 9. To find out more about ColOff® Please read and follow the instruction leaflet carefully before using the product! Consult your doctor for more information.