Fr6/Fr8/Fr10 Pediatric Dual-Lumen Silicone Foley Catheter with Balloon (with Guidewire)

HENAN AILE INDUSTRIAL CO., LTD with over 12 years of medical experience.
We hold certifications, including CE, ISO 13485 & USA FDA.

1. 100% Medical Grade Pure Silicone, Latex-Free Formula The whole catheter contains no natural latex protein, eliminating latex allergy risk for sensitive pediatric patients. Smooth silicone surface minimizes irritation to delicate urethral mucosa, reducing inflammation, encrustation and CAUTI (Catheter-Associated Urinary Tract Infection), suitable for medium-long term indwelling use.
2. Built-in Guidewire to Overcome Pediatric Intubation Difficulty Fr6, Fr8 and Fr10 are small sizes with soft tube body which easily kinks without guidewire. The medical stainless steel guidewire provides rigid support inside the catheter, guiding the tube smoothly along the physiological curve of urethra into bladder. It reduces false passage, urethral trauma and intubation failure. The guidewire can be easily pulled out after successful placement.
3. Independent Dual-Lumen Structure Two separated lumens for independent functions: one for continuous urine drainage, the other for balloon water inflation. The small balloon fits gently against the inner bladder wall after inflation to secure catheter position without excessive pressure on bladder mucosa.
4. Radiopaque Line Embedded in Tube Body Barium sulfate radiopaque marker integrated into the catheter, clearly visible under X-ray examination. Clinicians can verify catheter tip location inside the bladder to improve safety and facilitate radiological review.
5. Rounded Closed Tip & Polished Drainage Eyes Smooth rounded tip without sharp edges. Lateral drainage eyes are finely polished to reduce scratching during insertion and indwelling. Optimized eye size ensures smooth urine outflow and lowers blockage risk.
6. Mini Balloon Specially Designed for Pediatric Bladder 3ml balloon for Fr6, 5ml balloon for Fr8 and Fr10. The balloon inflates evenly and softly without overpressure on small pediatric bladder. It returns to smooth shape after deflation to avoid pulling injury during catheter removal.
7. Color-Coded Connectors for Quick Size Identification International standard color coding on ports helps medical staff quickly recognize French sizes, preventing wrong selection and improving efficiency in emergency and operating room settings.
8. EO Sterilized, Individual Sterile Pack, Single Use Ethylene oxide sterilized, non-pyrogenic, single blister pack for immediate use. Disposable design prevents cross contamination, with stable storage and long shelf life.

Product Overview

Fr6/Fr8/Fr10 Pediatric Dual-Lumen Silicone Foley Catheter with Balloon is a disposable indwelling urinary catheter specially designed for infants and young children. It adopts a two-lumen structure: one lumen for urine drainage and the other for balloon inflation. Equipped with an integrated removable guidewire, this catheter solves the clinical challenge of difficult catheterization caused by narrow pediatric urethra, greatly improving intubation success rate and minimizing urethral mucosal injury.

Made of 100% medical-grade pure silicone, EO sterilized and individually packed, this latex-free Foley catheter features excellent biocompatibility. Widely applied in pediatric wards, pediatric ICU, neonatal intensive care units and pediatric urology operating rooms, it is used for short-term and medium-long term indwelling catheterization, urine drainage and urine output monitoring for children.

Pediatric urethra is narrow and mucosal tissue is delicate. Ordinary thin catheters without guidewire tend to kink during insertion, leading to failed catheterization and urethral laceration. This pediatric Foley catheter with guidewire comes with a built-in guidewire to support the thin tube body during insertion, guiding the catheter along the natural curve of children’s urethra into the bladder. The guidewire can be withdrawn after proper placement, making it the preferred consumable for difficult pediatric catheterization.

Specification Table

Material Comparison: Pure Silicone vs Natural Latex vs Silicone-Coated Latex

1. 100% Pure Silicone (Our Product) Full medical silicone body, zero latex. Best biocompatibility, minimal mucosal irritation and less encrustation. Maximum recommended indwelling period up to 28 days for pediatric patients. Safe for latex-allergic children. Higher unit price. Recommended for medium-long term pediatric catheterization and difficult intubation with guidewire.
2. Natural Latex Foley Catheter Natural rubber substrate with low cost and good elasticity. Contains latex protein with high allergy risk for infants. Porous surface easily forms biofilm and crystal deposits. Strong mucosal irritation, only suitable for short-term use ≤7 days. Not recommended for long-term pediatric care, contraindicated for latex-sensitive patients.
3. Silicone-Coated Latex Foley Catheter Latex core covered by thin silicone coating. Mid-range cost. Once coating peels off, underlying latex may trigger allergy. Coating is vulnerable to wear, inferior biocompatibility compared to full silicone. Maximum indwelling time ≤14 days. Only for simple short drainage, not recommended for long-term pediatric use.

Application & Target Users / Scope

Application: Indwelling urinary catheterization for infants and children; continuous bladder urine drainage; precise hourly urine output monitoring for critically ill kids; relieve acute urinary retention; post-operative bladder drainage in pediatric urology; urine management for neurogenic bladder. Scope: Pediatric wards, neonatal ICU, pediatric emergency, pediatric urology, pediatric rehabilitation wards and overseas pediatric clinics. Target Users: Infants and young children; pediatric patients requiring indwelling catheter after surgery; children with acute urinary retention; neurogenic bladder patients; critically ill children for strict urine output monitoring; latex allergic children; pediatric patients with narrow urethra and difficult catheterization. Contraindications: Children with urethral laceration, urethral atresia, severe urethral trauma; patients with silicone allergy.

Why Choose Our Pediatric Dual-Lumen Silicone Foley Catheter with Guidewire

1. Customized for narrow pediatric urethra, pre-assembled guidewire solves intubation difficulty Fr6/8/10 small-bore catheters are inherently soft and prone to kinking without guidewire, leading to high failure rate in clinical practice. Our product includes guidewire inside each kit, no separate guidewire purchase required, simplifying pre-operation preparation. All-in-one kit is convenient for emergency and OR use, greatly reducing urethral trauma and false passage risk, an essential consumable for difficult pediatric catheterization.
2. Latex-free all-silicone formula, compliant with global pediatric hospital procurement policy Worldwide pediatric medical facilities widely adopt latex-free medical supply policies, and infants are high-risk group for latex allergy. 100% pure silicone eliminates latex allergy hazards, meeting tender and procurement requirements of overseas pediatric hospitals and expanding your customer base.
3. Kid-friendly mini balloon & ergonomic design 3ml/5ml micro balloon matches small bladder volume of children and avoids overpressure. Rounded tip, polished drainage eyes and radiopaque marker are all designed for delicate pediatric urethra, lowering complications and improving patient comfort.
4. Complete compliant certifications for bulk export orders Manufactured under ISO13485 quality control system with CE certification, EO sterile production. Support bulk orders and tender projects for overseas pediatric hospitals and distributors, stable quality and OEM available.
5. Lower total nursing cost for long-term indwelling Although unit price is higher than latex catheters, it can stay indwelled up to 28 days, reducing catheter replacement frequency, CAUTI and urethral injury complications, cutting nursing workload and overall healthcare expenditure.

FAQ 

Q1: What is the function of the guidewire included in this pediatric catheter? A1: Fr6/8/10 catheters have small diameter and soft tube body which easily kinks during insertion. The built-in guidewire provides structural support and guides the catheter along the urethra curve into bladder. It will be withdrawn after placement, lowering failure rate and mucosal injury risk.

Q2: Can the guidewire be reused? A2: The whole Foley catheter kit is single-use sterile medical consumable. The guidewire is disposable together with catheter. Reuse is prohibited and dispose as medical waste after use.

Q3: How long can this pediatric catheter remain indwelling? A3: Under professional medical supervision, maximum recommended indwelling duration for this 100% pure silicone pediatric catheter is 28 days. Latex catheters are only for short-term use within 7 days.

Q4: How much liquid should be injected into the balloon? Can air be used? A4: Inject 3ml sterile distilled water for Fr6 balloon, 5ml sterile distilled water for Fr8/Fr10 balloon. Never inflate the balloon with air, air leakage may cause catheter dislodgement.

Q5: What is the function of the radiopaque line on catheter? A5: Barium sulfate radiopaque material embedded in tube body. The catheter outline can be visualized under X-ray, so doctors confirm catheter tip is correctly positioned inside bladder.

Q6: Is it latex free? Can latex-allergic children use it? A6: The catheter is fully made of 100% medical silicone with no natural latex. It is safe for pediatric patients with latex allergy.

Q7: Which children cannot use this pediatric Foley catheter? A7: Contraindicated for patients with silicone allergy, complete urethral rupture, urethral atresia and active severe urethral bleeding. Urologist assessment of urethral condition is mandatory before insertion.

Q8: What is the shelf life of unopened sterile package? A8: 5-year shelf life for intact and unopened packages. Do not use if package is damaged or leaking.

Contact Us
Contact our export team at admin@aileindus.com for factory price quotes, technical data, or OEM product samples. We reply to all business inquiries within 12 hours.