Skip to content

Well Lead Endotracheal Tube with Evacuation Lumen A01F016010

by Well Lead Medical Co., Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06944932730434 UDI-DI Date27 Jan 2024ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-1876-2024 FDA Class I initiated 26 Feb 2024

    Complaints have been received that the device inflation tube detached and/or tore from the main tube, resulting in potential moisture buildup, loss of pressure, or inability to inflate. There were also reports the suction pump is difficult to connect or detaches during use.

    • Terminated Z-2243-2016 FDA Class II initiated 2 Jun 2016

    Parker Medical announces a voluntary field action for the Parker Trach-Vac Endotracheal Tubes - (Endotracheal tube,with Parker Flex-Tip,Sub-Glottic Suction, High Volume low Pressure) due to tube kinking during use.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Well Lead Endotracheal Tube with Evacuation Lumen
Generic Name
Basic endotracheal tube, single-use
Model / Reference
A01F016010
Primary DI / UDI-DI
06944932730434
510(k) Number
FDA Product Code
BTR, BSY
GMDN Term
Basic endotracheal tube, single-use
Device Class
Class II
Regulation Number
868.5730, 868.6810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic endotracheal tube, single-use

Cleared under the same submission (K110269)

Show all (12)

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No