FOLEY CATHETER (FOLEY BALLOON CATHETER)

Sterile · Single-Use · Indwelling Urinary Catheter

Product Overview:

The Foley Catheter (Foley Balloon Catheter) is a sterile, single-use indwelling urinary catheter. It is a thin, flexible tube made of natural latex, 100% coated with medical-grade solid silicone, which is passed through the urethra into the urinary bladder. The tube has two or three separate channels (lumens) running down its length: one lumen open at both ends drains urine into a collection bag, a second lumen with a valve connects to the retention balloon at the tip — inflated with sterile water to hold the catheter in place — and, in the 3-Way variant, a third lumen provides a route for continuous bladder irrigation. Available in 2-Way and 3-Way configurations across a full range of French sizes, the catheter supports reliable and comfortable urine drainage during the intended period of use.

Foley Balloon Catheter — 2-Way indwelling urinary catheter with retention balloon and drainage eyes

Technical Specifications

Product Name Sterile Foley Balloon Catheter
Generic Name Foley Balloon Catheter
Device Category Indwelling Urinary Catheter
Variants 2-Way and 3-Way
Available Sizes (French / Fr) 2-Way: FR 6, 8, 10, 12, 14, 16, 18, 20, 22, 24;  3-Way: FR 14, 16, 18, 20, 22, 24
Tube Material Natural latex, 100% coated with medical-grade solid silicone
Funnel / Valve Material Natural latex drainage and inflation funnels; soft natural latex coloured valve
Tip Configuration Soft, rounded closed tip with drainage eyes
Retention Balloon Inflated with sterile water only (do not use air); safe and symmetrical inflation
Radio-opaque Line Yes — radio opacity
Sterilization Ethylene Oxide (EO) gas (20% EO : 80% CO2)
Sterility EO sterile · Pyrogen-free
Usage Single use / disposable
Storage Conditions 0–40 °C, RH 0–70%; store in a cool, dry and dark place; do not expose above 49 °C
Device Classification Class B (MDR-2017, India)
Quality System Manufactured under ISO 13485:2016 certified facility

Key Features

  • Manufactured from natural latex, 100% coated with medical-grade solid silicone.
  • Soft, rounded closed tip with drainage eyes for effective urine drainage.
  • Proximal end with drainage and inflation funnels and a hard valve for smooth inflation and deflation.
  • Radio-opaque line for radiographic positioning.
  • Special latex formulation and multi-dip process for flexibility and kink-resistant walls.
  • Retention balloon with safe and symmetrical inflation — inflate with sterile water only.
  • 2-Way and 3-Way configurations; the 3-Way adds an irrigation lumen for bladder irrigation.
  • Available in a full range of French sizes (FR 6–24) for adult and paediatric use.
  • Sterile (EO), pyrogen-free and disposable — single use only. 

Intended Use
The Foley Catheter is intended for urinary bladder catheterization to facilitate continuous drainage of urine from the urinary bladder into a compatible urine collection system. It is inserted through the urethra into the urinary bladder and is retained in position by an inflatable balloon located near the distal tip. The catheter may be indicated for acute or chronic urinary retention, bladder outlet obstruction, perioperative bladder drainage, accurate monitoring of urine output in critically ill patients, and other clinical conditions where indwelling urinary catheterization is clinically indicated. It is intended for all age groups and for use by, or under the supervision of, a qualified healthcare professional trained in urinary catheterization.

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