Wei Nasal Jet Tube

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 Nasal Jet Tube EUDAMED

Nasal Jet Tube GUDID

Generic Name

Nasopharyngeal airway, single-use

Model / Reference

A06A067010, Nasal Jet Tube

FDA applicant

Well Lead Medical Co., Ltd.

Primary DI / UDI-DI

06944932776265

Basic UDI-DI

69449327FA06A06DD

510(k) Number

K211543 ↗

FDA Product Code

BTR

EMDN Code

R010101 Nasopharyngeal tubes

GMDN Term

Nasopharyngeal airway, 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 the Wei Nasal Jet Tube designed for, and how does it differ from traditional ventilation methods?

  The Wei Nasal Jet Tube is specifically designed for supraglottic jet oxygenation and ventilation during anesthesia procedures, particularly when respiratory inhibition or hypoxia is a concern. Unlike conventional ventilation methods, it delivers active, pulsatile oxygen via integrated channels, allowing for respiratory support without requiring direct tracheal intubation. This makes it useful in monitored anesthesia care settings where quick, non-invasive oxygenation is needed, such as during procedures where airway control may be temporarily compromised.

• Is the Wei Nasal Jet Tube intended for single-use or reusable applications, and what does this mean for clinical workflow?

  The Wei Nasal Jet Tube is single-use only, meaning each device is sterile and intended for one patient encounter. This design ensures patient safety by eliminating cross-contamination risks and simplifies clinical workflows, as no reprocessing or sterilization steps are required between uses. Clinicians should discard the device after use and open a new, sterile unit for subsequent patients.

• What regulatory pathways has the Wei Nasal Jet Tube followed, and how does this affect its availability?

  The Wei Nasal Jet Tube has undergone FDA 510(k) clearance (K211543) and complies with EU MDR (Medical Device Regulation) standards, classifying it as a Class II (BTR) device. These pathways confirm its safety and performance for supraglottic jet ventilation in anesthesia settings. Availability is supported by these regulatory approvals, ensuring it meets stringent quality and efficacy standards for use in monitored anesthesia care environments.

• How is the Wei Nasal Jet Tube supplied, and what storage conditions should be followed to maintain its integrity?

  The Wei Nasal Jet Tube is supplied as a sterile, single-use device in individual packaging, ready for immediate clinical use. To preserve sterility and functionality, it should be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Avoid exposing the packaging to moisture or contamination, as this could compromise the device’s integrity before use.