ISO 13485:2016 Certified Manufacturing

Designed for safe, reliable urinary catheterization in veterinary patients, this Foley catheter is produced from medical-grade silicone rubber, offering excellent biocompatibility, low tissue irritation, and reduced risk of urinary tract infection. A uniquely designed tube body with a smooth, atraumatic tip minimizes mucosal damage and reduces resistance during insertion, supporting a smoother catheterization process across a wide range of veterinary patients.

The tube body incorporates a radiopaque line for clear visualization of catheter position under X-ray. A professionally engineered, uniform balloon design helps prevent urine leakage and accidental catheter dislodgement, while fixed wings on each catheter provide a secure anchor point for external stabilization and taping.

Key Features:

• ISO 13485:2016 certified quality management system
• Medical-grade silicone — biocompatible, non-irritating, reduced UTI risk
• Smooth, atraumatic tip design to protect mucosa and ease insertion
• Radiopaque line for X-ray visualization of catheter position
• Uniform balloon design to prevent leakage and catheter displacement
• Fixed wings for secure external stabilization
• Sterile, single-use, latex-free

Available Sizes

All sizes include fixed wings.

Manufactured in an ISO 13485:2016-certified facility. For veterinary use only — not for human use.

Warranty Policy

LIMITED WARRANTY — VETERINARY USE ONLY (VUO) DISPOSABLE CONSUMABLES

0. Intended Use Notice This product is labeled and sold strictly for Veterinary Use Only. It is not intended, labeled, or authorized for use in the diagnosis, treatment, prevention, or clinical management of any disease or condition in humans. This product is not a human medical device and has not been evaluated or cleared for human clinical use. Veterinary medical devices of this type are generally not subject to premarket clearance by FDA's Center for Veterinary Medicine (FDA-CVM), which primarily regulates animal drugs, feed, and certain veterinary biologics rather than veterinary hardware/devices. This warranty applies solely to the product's condition and manufacturing quality as delivered for veterinary clinical use.

1. Warranty Provider and Scope The warranty is provided and conducted strictly by the manufacturer of this particular product, not by Medaza, Inc. The manufacturer warrants to the original purchasing entity ("Buyer") that, at the time of shipment, this disposable consumable product is free from defects in materials and workmanship, and conforms to its published specifications, provided the product's original packaging and sterile barrier (if applicable) remain unopened and intact.

Because this product is a single-use, disposable item, this warranty is strictly limited to manufacturing and packaging defects discovered prior to use and does not constitute a general performance, durability, or time-based warranty. Once a unit's packaging has been opened or the unit has been used, it is no longer eligible for warranty claim, regardless of remaining inventory age.

2. Claim Window A warranty claim must be submitted within thirty (30) days of receipt of the shipment, or before the product's labeled expiration date, whichever is earlier. Claims submitted outside this window will not be honored.

3. Depot/Reporting-Only Return Procedure Warranty service for disposable consumables is handled as a reporting and credit/replacement process, not a repair process.

• First Step (Intake): The Buyer must not contact the manufacturer directly. The Buyer must contact Medaza, Inc. first by email at contactusa@medaza-platform.com, including lot number, quantity affected, photos of the defect and packaging, and date of receipt.
• Delegation: Medaza,Inc. will coordinate with the manufacturer to validate the claim and determine whether replacement, credit, or return is appropriate. If a physical return is required for manufacturer inspection, Medaza,Inc. will secure a Return Merchandise Authorization (RMA) number before any shipment is accepted.
• No Unauthorized Returns: No shipments will be accepted by the manufacturer's facility without an active, authorized RMA number.

4. Allocation of Shipping Costs For validated manufacturing-defect claims, the manufacturer will cover reasonable inbound and outbound shipping costs for the affected units. For claims found not to be a manufacturing defect (see Section 6), the Buyer is responsible for all associated shipping costs.

5. Universal Recall & Systemic Defect Exception If the affected lot is officially determined by the manufacturer, Medaza,Inc, or an authorized regulatory or safety body (e.g., FDA-CVM) to be subject to a Universal Recall, Safety Alert, or a verified batch-wide Systemic Manufacturing Defect, the manufacturer will cover full replacement and standard two-way ground shipping costs for all affected units, regardless of the 30-day claim window in Section 2.

6. Warranty Exclusions This warranty does not cover:

• Any unit where the original packaging or sterile barrier has been opened, breached, or tampered with.
• Damage caused by improper storage (including temperature/humidity excursions outside labeled conditions), accident, abuse, liquid exposure, neglect, or improper handling by the Buyer.
• Products used past their labeled expiration date.
• Normal variability in disposable consumables that falls within published specification tolerances.
• Any use of the product outside of veterinary clinical settings, including any off-label human clinical, diagnostic, or therapeutic use.
• Indirect, incidental, or consequential costs arising from use of a defective unit (e.g., cost of a repeated clinical procedure, delayed treatment, or lost clinic time).

7. Disclaimer of Human-Use Warranties Because this product is designated Veterinary Use Only, no warranty — express or implied — is made regarding its suitability, safety, or fitness for use in humans, or for any human clinical, diagnostic, or therapeutic application. Buyer assumes full responsibility for confirming the product's suitability for its intended veterinary application and for compliance with all applicable state veterinary practice regulations.