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Well Lead Endotracheal Tube with Evacuation Lumen A01F017510

by Well Lead Medical Co., Ltd

Ref A01F05751FModel Standard Tracheal Tube HVLP cuffed: 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0,18.5, 9.0, 9.5,10.0, 10.5, 11.0 mm

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06944932729643 UDI-DI Date27 Jan 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69449327FA01A00BW Basic UDI-DI 06944932729643UDI-DIDate2 Jul 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

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

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Welllead Tracheal Tube with Evacuation Lumen EUDAMED
Well Lead Endotracheal Tube with Evacuation Lumen GUDID
Generic Name
Basic endotracheal tube, single-use
Device Name
Tracheal Tube
Model / Reference
Standard Tracheal Tube HVLP cuffed: 3.0 EUDAMED
3.5 EUDAMED
4.0 EUDAMED
4.5 EUDAMED
5.0 EUDAMED
5.5 EUDAMED
6.0 EUDAMED
6.5 EUDAMED
7.0 EUDAMED
7.5 EUDAMED
8.0 EUDAMED
18.5 EUDAMED
9.0 EUDAMED
9.5 EUDAMED
10.0 EUDAMED
10.5 EUDAMED
11.0 mm EUDAMED
A01F05751F EUDAMED
A01F017510 GUDID
Primary DI / UDI-DI
06944932729643
Basic UDI-DI
69449327FA01A00BW
510(k) Number
FDA Product Code
BTR, BSY
EMDN Code
R01030201 Endotracheal tubes, cuffed, not reinforced
GMDN Term
Basic endotracheal tube, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
868.5730, 868.6810
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

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

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Properties

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

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No