MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER

• K Number: K971759
• Device Name: MEDPORT EMERGENCY MEDICATION AIRWAY TUBE ADAPTER
• Manufacturer: GREEN FIELD MEDICAL SOURCING, INC.
• Date Cleared: 1998-03-02 ( 294 days)
• Product Code: BTR
• Regulation Number: 868.5730
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

• 1. To establish a path in which to inject medication into the lungs of a patient who has undergone cardiac and/or pulmonary arrest and who is being ventilated through an intubated airway.
• 2. To establish a means in which to introduced medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.
• 3. To provide an alternative means other than intravenous injection for administering lifesaving drugs when a patient is being assisted by an endotracheal ube.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "MedPort™ Emergency Medication Airway Tube Adapter." It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets them.

Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).