The BARDEX� I.C. anti-infective latex Foley catheter is clinically proven to reduce catheter associated urinary tract infections. Incorporating a technologically-advanced formulation consisting of Bacti-Guard�* silver alloy coating and BARD� hydrogel, the BARDEX� I.C. Foley catheter dramatically reduces bacterial adherence and minimizes biofilm formation.
PRESCRIPTIVE INFORMATION FOR FOLEY CATHETERS, DRAINAGE BAGS AND URINE METERS
INDICATIONS FOR USE: For urological use only.
CAUTIONS
� Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
� Do not aspirate urine through drainage funnel wall.
� Some Foley catheters may contain Natural Rubber Latex which may cause allergic reactions. Please check package.
� Contains or Presence of Phthalates: Di(2-ethylhexyl)phthalate (DEHP) is a plasticizer used in some polyvinyl chloride
medical devices. DEHP has been shown to produce a range of adverse effects in experimental animals, notably liver
toxicity and testicular atrophy. Although the toxic and carcinogenic effects of DEHP have been well established in
experimental animals, the ability of this compound to produce adverse effects in humans is controversial. There is no
evidence that neonates, infants, pregnant and breast feeding women exposed to DEHP experience any related adverse
effects. However, a lack of evidence of causation between DEHP-PVC and any disease or adverse effect does not mean that
there are no risks.
� With Temperature-Sensing Probes, in the presence of RF energy sources, local heating, temperature errors, and probe
damage may occur. In medical use, unplug the temperature-sensing catheter at the temperature monitor before activating
electrosurgical or other types of direct coupled RF energy sources. Do Not Stretch Catheter. This will cause repositioning of
the probe. Do not use Stylet. This will cause stretching of catheter.
WARNINGS
� On catheter, do not use ointments or lubricants having a petrolatum base. They will damage latex and may cause balloon
to burst.
� After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice
and applicable local, state and federal laws and regulations.
� Visually inspect the product for any imperfections or surface deterioration prior to use. Use Luer tip syringe to inflate with
stated mL of sterile water OR for pre-filled products, remove clip and squeeze reservoir to inflate with stated mL of sterile
water.
� Store catheters at room temperature away from direct exposure to light, preferably in the original box.
