Trach Mate Tracheal Tube
by Mccormick Laboratories, Inc.
510(k) K870470
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK870470 | Date8 May 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BTR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5730
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Trach Mate Tracheal Tube is a tracheal tube designed for securing in tracheostomy procedures. It is classified as a tube, tracheal (with or without connector) and is intended for use in maintaining an open airway for patients requiring mechanical ventilation or prolonged respiratory support. The device is engineered to facilitate secure placement and stabilization of the tracheal tube within the tracheostomy site, reducing the risk of displacement or obstruction.
This tracheal tube is supplied as a single-use medical device and is intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. It is not sterile at the time of shipment but is packaged in a manner suitable for terminal sterilization using ethylene oxide or gamma radiation. The device is classified under FDA regulation number 868.5730 and holds a 510(k) clearance (K870470) from the FDA, with a decision date of May 8, 1987. Multiple model and reference codes are associated with this product, ensuring compatibility with various tracheostomy systems.
Questions
AI-generated answers, 1 Oct 2026
What is the Trach Mate Tracheal Tube designed for?
The Trach Mate Tracheal Tube is specifically engineered to maintain an open airway in patients requiring mechanical ventilation or prolonged respiratory support. It is intended for secure placement and stabilization within a tracheostomy site, minimizing the risk of displacement or obstruction during critical care procedures.
How is the Trach Mate Tracheal Tube supplied and prepared for use?
The device is supplied as a single-use medical product and is not sterile at the time of shipment. It is packaged to allow terminal sterilization using either ethylene oxide or gamma radiation, ensuring compatibility with clinical sterilization protocols before use.
Is the Trach Mate Tracheal Tube reusable or intended for single-use?
The Trach Mate Tracheal Tube is explicitly designed for single-use only. This classification aligns with clinical best practices for tracheostomy tubes to prevent cross-contamination and ensure patient safety, particularly in high-risk settings like intensive care units.
What model or reference codes should I consider for compatibility with my tracheostomy system?
The Trach Mate Tracheal Tube supports multiple model and reference codes to ensure compatibility with various tracheostomy systems. These include codes such as 1825146, 1018233, 3007740622, and others listed under FDA registration. Always verify the specific code required for your clinical setup to avoid mismatches.
How should the Trach Mate Tracheal Tube be stored before terminal sterilization?
The device should be stored in its original packaging to maintain sterility integrity after terminal sterilization. Prior to sterilization, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines for proper handling to ensure the tube remains functional and safe for use.