FOLEYCATH®

NR Latex Balloon Catheters, Sterile

Ulitimate Comfort Protection

In an effort to improve clinical, economic and patient satisfaction, FOLEYCATH® Natural Rubber Catheters are innovatively designed with silicone elastomer bonding to provide a smooth exterior surface for maximum comfort and added protection against urethral irritation.

Sterilized with gamma irradiation, the catheters offer exceptional performance with the following features:

  • Reinforced tip and flexible shaft for smooth insertion and removal
  • Optimum lumen size and shape for fast and efficient flow
  • Large and smooth eyelets provide excellent drainage and tip strength
  • Strong and symmetrical balloon
  • Visible color code for size identification

NR Latex Balloon Catheters, Sterile Special

Type 2-way & 3-way balloon catheters (plastic valve/rubber valve), silicone elastomer bonded and Gamma sterilized
Primary Materials Natural rubber latex
Packing 1 catheter per pouch, 10 pouches (2-way) / 5 pouches (3-way) per dispenser and 20 dispensers per carton
Product Conformance Conform to BS EN 1616:1997, ASTM F623 and MS1369:1995
Quality Assurance Manufacturing process is in compliance with BS EN ISO13485 Quality System

  • Store in cool dry place
    Store in cool dry place
  • Do not expose to water
    Do not expose to water
  • Single use only
    Single use only

Pre-shipment Quality Inspection:

Inspection Criteria Insp. Level AQL
Balloon Inspection G-II Major:0.65/Minor:2.5
Visual Inspection G-II Major:0.25/Minor:2.5
Finish Inspection G-II Critical:0.15/Major:0.65/Minor:1.0
Fuctional Inspection N = 5, N = 2 N/A
Dimensional Inspection N = 2 N/A

Functional Inspection:

Test Conducted Per BS EN 1616:1997
Flowrate. Integrity of the junction between inflation funnel and shaft of catheter. Security of fit of connector to the drainage funnel. Inflation lumen leakage and / or balloon deflation. Occlusion of drainage eyes and leakage from balloon.

Dimensions

Size (Ch/Fr) Balloon Capacity (ml/cc) Tip Length (mm), max Gauge Size Range (mm) Eye Length (mm) Width of Drainage Eye(mm)
      Nominal Diameter Tolerance    
6 3 30 2.00 -0.33 + 0.67 1.6 ± 0.7 0.30-0.60
8 3-5 30 2.66 -0.33 + 0.67 2.4 ± 0.7 0.45-0.90
10 3-5 30 3.33 -0.33 + 0.67 2.7 ± 0.7 0.55-1.10
12 5-15 30 30 40 4.00 -0.33 + 0.67 3.5 ± 0.7 0.60-1.40
14 5-15 30 30 40 4.66 -0.33 + 0.67 4.5 ± 0.7 0.85-1.70
16 5-15 30-45 30 40 5.33 -0.33 + 0.67 5.5 ± 0.7 1.20-2.40
18 5-15 30-45 30 40 6.00 -0.33 + 0.67 5.5 ± 0.7 1.20-2.40
20 5-15 30-45 30 40 6.66 -0.33 + 0.67 5.8 ± 1.0 1.60-3.30
22 5-15 30-45 30 40 7.33 -0.33 + 0.67 5.8 ± 1.0 1.60-3.30
24 5-15 30-45 30 40 8.00 -0.33 + 0.67 6.5 ± 1.2 2.00-4.20
26 5-15 30-45 30 40 8.66 -0.33 + 0.67 6.5 ± 1.2 2.00-4.20
28 5-15 30-45 30 40 9.33 -0.33 + 0.67 7.0 ± 1.2 2.45-4.90
30 5-15 30-45 30 40 10.00 -0.33 + 0.67 7.0 ± 1.2 2.45-4.90

Overall, Effective and Funnel Length:

Catheter Type Overall (mm) Effective (mm) Funnel (mm)
2-way Paediatric (size 6-10) min. 240 min. 200 min. 35
2-way Female (size 12-26) min. 210 min. 130 min. 35
2-way Male (size 12-30) min. 380 min. 275 min. 35
3-way Male (size 16-26 of 30-45ml) min. 380 min. 275 min. 35