SPECIFICATIONS FOR ROMED FOLEY BALLOON CATHETERS WITH SILICONE ELASTOMER BONDED
This ROMED Standard specifies dimensional and performance requirement for sterile, single-use, flexible urethral balloon-retention catheter of the foley type with nelaton tip, funnel end and luer valve. Two way catheters have two eyes and three way catheters have three eyes. The product is manufactured in natural latex and is sterilized for single-use only. Length 40 cm.
MATERIALS
Silicon elastomer bonded
Natural rubber latex, medical quality
Sulphur
Zinc oxide
Silicone
Promotor ZDC
Promotor DM
BHT
Casein
Silica gel
STERILISATION
Foley balloon catheters are sterilised by means of gamma radiation. Sterility is guaranteed for a period of 5 years if package remains unopened.
GAUGE SIZE
The size of the catheter shall be designated by the charrière gauge system and by the equivalent nominal external diameter of the shaft expressed in millimetres.
Note: The charrière gauge system of measurement is based on the external diameter of the catheter gauge in steps of third of a millimetre, the charrière gauge size being three times the external diameter expressed in millimetres.
TIP
For catheter size 16 Fr and above, the tip is reinforced.
DRAINAGE EYES
Catheter shall have one pair of drainage eyes which shall be located at an angle of 180 relative to one another, the eyes shall be opposite.
USE Should not stay in the body for more than 4 days.
BALLOON
Type 2-way standard Size (Fr or Ch.) 12-30 Balloon capacity (ml/cc) 10-30
Available Sizes:
CATH10-14 2 Way 10ml Silicone Treated size 14
CATH10-16 2 Way 10ml Silicone Treated size 16
CATH10-18 2 Way 10ml Silicone Treated size 18
CATH10-20 2 Way 10ml Silicone Treated size 20
CATH10-22 2 Way 10ml Silicone Treated size 22
Caution: This product contains natural rubber latex which may cause allergic reactions.
Packing: packed per piece, 10 pieces in an innerbox, 10 innerboxes in an export carton.
