Well Lead Endotracheal Tube with Evacuation Lumen
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Welllead Tracheal Tube with Evacuation Lumen EUDAMEDWell Lead Endotracheal Tube with Evacuation Lumen FDA UDI
- Generic Name
- Basic endotracheal tube, single-use FDA UDI
- Device Name
- Tracheal Tube EUDAMEDPVC Cuff 8.0 FDA UDI
- Model / Reference
- 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 EUDAMEDA01F05801F EUDAMEDA01F018010 FDA UDI
- Description
- PVC Cuff 8.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932729650 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FA01A00BW EUDAMED
- 510(k) Number
- K110269 FDA UDI
- FDA Product Code
- BTR FDA UDIBSY FDA UDI
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMED
- GMDN Term
- Basic endotracheal tube, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5730 FDA UDI868.6810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Basic endotracheal tube, single-use
Well Lead Endotracheal Tube with Evacuation Lumen by Well Lead Medical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Basic endotracheal tube, single-use.
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Cleared under the same submission
K110269 also covers:
- KENOREX — KENTRON HEALTH CARE, INC.
- KENOREX — KENTRON HEALTH CARE, INC.
- KENOREX — KENTRON HEALTH CARE, INC.
- KENOREX — KENTRON HEALTH CARE, INC.
- KENOREX — KENTRON HEALTH CARE, INC.
- KENOREX — KENTRON HEALTH CARE, INC.
- KENOREX — KENTRON HEALTH CARE, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (2)
- FDA UDI 50dbced5-689a-48ef-a689-99b974f92964 34 fields · synced Jul 9, 2026
- EUDAMED e4bddf3b-2d1a-461f-b0bd-574b61bc3eda 61 fields · synced Jul 9, 2026