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Tri-Med Model 126 Sample Line W/Extended Life Nafi

FDA 510(k)

Class II (US FDA 510(k))

510(k) K850746

by Tri-Med, Inc.

Identifiers

510(k) Number
K850746 FDA 510(k)
FDA Product Code
CCK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1400 FDA 510(k)
Regulation Number
868.1400 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Tri-Med Model 126 Sample Line with Extended Life Nafi is a respiratory tubing device designed for use in anesthesia systems. It facilitates the collection and transport of respiratory gases, enabling monitoring and sampling of patient breath during surgical procedures. The extended-life Nafi material enhances durability and reduces the risk of contamination or degradation over repeated use.

This device is supplied as a reusable component and is intended for use in operating rooms or anesthesia settings. It is not sterile and requires cleaning and maintenance between uses. The Model 126 is classified under product code CCK and holds an FDA 510(k) clearance (K850746) for substantial equivalence, as reviewed by the Anesthesiology Advisory Committee. Storage and handling should follow manufacturer guidelines to ensure proper function and safety.

Frequently asked questions

What is the primary purpose of the Tri-Med Model 126 Sample Line with Extended Life Nafi in an operating room setting?

The Tri-Med Model 126 Sample Line is designed specifically for anesthesia systems to collect and transport respiratory gases during surgical procedures. Its role is to enable continuous monitoring and sampling of a patient’s breath, ensuring accurate analysis of inhaled and exhaled gases for clinical decision-making.

Is this device intended for single-use or can it be reused? How does the manufacturer recommend handling it between uses?

This device is not single-use and is supplied as a reusable component. Since it is not sterile, it requires thorough cleaning and maintenance between uses to prevent contamination or degradation. Following the manufacturer’s guidelines for storage and handling is essential to ensure proper function and safety.

What material is used in the Tri-Med Model 126, and how does it benefit the device’s performance?

The device features an extended-life Nafi material, which improves durability and reduces the risk of contamination or degradation over repeated use. This enhances reliability in anesthesia systems where consistent performance is critical during surgical procedures.

How is this device regulated by the FDA, and what does its clearance status mean for clinical use?

The Tri-Med Model 126 holds an FDA 510(k) clearance (K850746), determined through substantial equivalence review by the Anesthesiology Advisory Committee. This means it has been evaluated as comparable to a legally marketed device and meets regulatory standards for safety and effectiveness in its intended use within anesthesia systems.

What type of environment is this device intended for, and are there any special storage instructions?

The device is designed for use in operating rooms or anesthesia settings where respiratory gas sampling is required. While specific storage instructions are not detailed in the data, the manufacturer recommends adhering to guidelines to maintain functionality and safety, particularly given its reusable nature and exposure to clinical environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tri-med Model 126 Sample Line W/Extended Life Nafi, PDF K850746 - Tri-med Model 126 Sample Line W/Extended Life Nafi, Tri-med Model 126 Sample Line W/extended Life Nafi 510 (k) K850746 ..., fda.innolitics.com, Tri-Med,Inc - Specializing in Respiratory Equipment and Supplies-Since 1995

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tri-Med, Inc.

Sources (1)

  • FDA 510(k) K850746 24 fields · synced Sep 20, 2026