Rusch Tracflex Plus Pediatric Tracheostomy Tube Set

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls on record, checked 22 Oct 2026.

Trade Name

Tracheostomy Tube

Device Name

CrystalClear / CrystalClear Plus Tracheostomy Tube Set

Model / Reference

121300-000095

Primary DI / UDI-DI

14026704943507

Basic UDI-DI

08019020000000000000150KC

510(k) Number

K133173 ↗

FDA Product Code

JOH

EMDN Code

R0105010101 Tracheostomic cannulas, cuffless, not reinforced, with fixed flange, and kits

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 868.5800

Market of Registration

Ireland

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• ONCONTROL BONE LESION BIOPSY TRAY, 10/12 ga 15/19 cm

  Class IIa

  CE/MDR

• MANTA 14F Depth Locator

  Class IIa

  CE/MDR

• Hem-O-Lok Applier Medium Large 8" Curved Refurbished

  Class I

  CE/MDR

• Hem-O-Lok Applier Extra Large 11" Curved Refurbished

  Class I

  CE/MDR

• ONCONTROL BONE MARROW NEEDLE SET, 3.0mm x 152mm

  Class IIa

  CE/MDR

• ONCONTROL BONE LESION BIOPSY TRAY, 11/13 ga 10/14 cm

  Class IIa

  CE/MDR

See all devices from Teleflex Medical, LLC →

• What clinical settings is this pediatric tracheostomy tube set designed for, and why is it optimized for smaller airways?

  The Rusch Tracflex Plus Pediatric Tracheostomy Tube Set is specifically designed for clinical settings like operating rooms, intensive care units, and emergency departments where pediatric tracheostomy care is required. It features a reinforced inner and outer cannula to enhance stability and reduce obstruction in smaller airways, which is critical for pediatric patients due to their narrower airway anatomy.

• Is this device single-use or reusable, and how is it supplied?

  This device is explicitly labeled as single-use and is supplied sterile, packaged individually. This ensures patient safety and reduces the risk of cross-contamination, which is particularly important in pediatric care where infection control is paramount.

• What sizes and configurations are available for this pediatric tracheostomy tube set?

  The set includes a range of sizes tailored for pediatric use, as indicated by the multiple FEI numbers (e.g., 3009771213, 3021632375, etc.). These variations ensure compatibility with different pediatric tracheostomy procedures and patient sizes, providing flexibility for clinicians.

• How is this device regulated, and what advisory committee was involved in its clearance?

  The Rusch Tracflex Plus Pediatric Tracheostomy Tube Set is cleared under the FDA 510(k) pathway and adheres to MDR (Medical Device Regulation) standards. Its clearance was determined by the Anesthesiology advisory committee (AN), reflecting its intended use in procedures involving airway management.

• Why is sterility important for this device, and how should it be stored?

  Sterility is critical for this single-use tracheostomy tube set to prevent infections, especially in vulnerable pediatric patients. While the device is supplied sterile, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until use.