Endotracheal Tube with Evacuation Lumen

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 found in the data synced 22 Oct 2026.

Trade Name

Welllead Tracheal Tube with Evacuation Lumen EUDAMED

Endotracheal Tube with Evacuation Lumen GUDID

Generic Name

Basic endotracheal tube, single-use

Model / Reference

A01G04654F, Standard Tracheal Tube, PU cuffed, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, 10.0 mm

FDA applicant

Well Lead Medical Co., Ltd.

Primary DI / UDI-DI

06944932784048

Basic UDI-DI

69449327FA01G01CW

510(k) Number

K182739 ↗

FDA Product Code

BTR

EMDN Code

R01030201 Endotracheal tubes, cuffed, not reinforced

GMDN Term

Basic endotracheal tube, single-use

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 868.5730

EU market of registration

Germany

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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• What clinical scenarios is this endotracheal tube designed to support during procedures?

  This device is specifically designed for airway management in anesthesia and critical care settings, where suctioning secretions or fluids is a frequent requirement. The integrated evacuation lumen reduces the need for repeated removal and reinsertion of the tube, which can be critical during prolonged procedures, surgeries, or in intensive care units where patient stability must be maintained without disruption.

• Is this device reusable, or is it intended for single-use only?

  The device is explicitly intended for single-use in controlled clinical environments like operating rooms or intensive care units. This design ensures patient safety by preventing cross-contamination and maintaining sterility for each procedure.

• How should I store this endotracheal tube to ensure it remains sterile and functional?

  The device must be stored in a clean, dry environment to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, it should remain unopened until immediately before use, and any packaging should be kept intact to avoid contamination.

• What sizes are available for this endotracheal tube, and how do I determine the correct size for a patient?

  The device is available in multiple sizes, as indicated by the extensive list of registration numbers (e.g., 3002808466, 3005580113, etc.), which correspond to different internal diameters and lengths. The correct size is typically determined by the patient’s anatomy, age, and clinical needs, such as tracheal diameter or cuff size, and should be selected based on standard medical guidelines or institutional protocols.

• Can this device be used safely in an MRI environment, and if so, what precautions should be taken?

  Yes, this device adheres to MRI safety standards for non-ferromagnetic materials, meaning it is safe to use in MRI environments. However, standard MRI precautions should still be followed, such as ensuring the device is compatible with the specific MRI system being used and confirming there are no metallic components that could interfere with imaging or pose a risk to the patient.