Endotracheal Tube with Evacuation Lumen
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Welllead Tracheal Tube with Evacuation Lumen EUDAMEDEndotracheal Tube with Evacuation Lumen FDA UDI
- Generic Name
- Basic endotracheal tube, single-use FDA UDI
- Device Name
- Tracheal Tube EUDAMEDPU Cuff 7.5 DEHP FREE FDA UDI
- Model / Reference
- A01G04754F EUDAMEDFDA UDIStandard 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 EUDAMED
- Description
- PU Cuff 7.5 DEHP FREE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932784086 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FA01G01CW EUDAMED
- 510(k) Number
- K182739 FDA UDI
- FDA Product Code
- BTR 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 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
Endotracheal Tube with Evacuation Lumen by Well Lead Medical Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Basic endotracheal tube, single-use.
- AVANOS — Avanos Medical, Inc. · Class II
- Parker Flex-Tip — SALTER LABS · Class II
- Mallinckrodt — Covidien LP · Class II
- RediTube™ — Airlife, Inc. · Class II
- Medline Industries, Inc. — MEDLINE INDUSTRIES, INC. · Class II
- Endotracheal Tubes — Dynarex Corp. · Class II
- ULTRAMED ENDOTRACHEAL TUBE ORAL/NASAL CUFFED Size 3 — Ultra For Medical Products (Ultramed) U.M.I.C (S.A.E) · Class IIa
- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
Cleared under the same submission
K182739 also covers:
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- RUSCH — TELEFLEX INCORPORATED
- Endotracheal Tube with Evacuation Lumen — Well Lead Medical Co., Ltd
- Endotracheal Tube with Evacuation Lumen — Well Lead Medical Co., Ltd
- Endotracheal Tube with Evacuation Lumen — Well Lead Medical Co., Ltd
- Endotracheal Tube with Evacuation Lumen — Well Lead Medical Co., Ltd
- Endotracheal Tube with Evacuation Lumen — Well Lead Medical Co., Ltd
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Well Lead Medical Co., Ltd
Sources (2)
- FDA UDI 18cf6323-b448-4e9d-a127-e3f62da6e32e 34 fields · synced Aug 4, 2026
- EUDAMED 4cecc590-e793-44f5-b49e-9f3e0edfa5b0 61 fields · synced Aug 4, 2026