Description

The Coronary Angio Pack is a comprehensive, sterile, single-use medical device kit meticulously designed for cardiac and vascular catheterization procedures, such as angiography and angioplasty. This kit is essential for healthcare professionals aiming to maintain a sterile field while diagnosing or treating cardiac blockages.

Key Features

• Sterility and Single-Use Design: Ensures a safe, contamination-free environment for each procedure.
• Customizable Components: Available with or without manifolds, drapes, and surgical instruments to meet specific procedural needs.

Comprehensive Kit Components

The pack includes a variety of high-quality components:

• Manifolds (HDPE; 2 or 3 port)
• Introducer Needle (stainless steel)
• Hemostasis Y Connector
• High Pressure Tubing (PU)
• Control Syringe (PC & TPR)
• Inflation Device (PC/ABS)
• Angiographic Syringes (various sizes)
• Drapes and Gowns: Includes polybacked drapes, angio drapes, and reinforced gowns.
• Surgical Instruments: Scissors, forceps, needle holder, and more.

Material Specifications

• Made from high-quality materials such as SMS nonwoven, polypropylene, and stainless steel.
• Sterilized using ethylene oxide, ensuring non-pyrogenic conditions.

Regulatory Compliance

• Classified as Class IIa under EU MDR 2017/745 and Class B under Indian Medical Device Rule-2017.
• CE and ISO13485 certified, highlighting adherence to international standards.

Safety and Handling

• Latex-Free: Suitable for all age groups.
• Non-Toxic Packaging: Medical-grade, ensuring sterility.
• Contraindications: Includes considerations such as patient weight, pregnancy, and allergies to contrast media.

Storage Instructions

• Store at temperatures between 15°C to 40°C with 50–75% relative humidity.
• Keep dry and away from sunlight to maintain sterility.
• Shelf life of three years from the date of manufacture.

This Coronary Angio Pack is an indispensable tool for medical professionals, offering reliability and versatility in critical cardiac procedures.