Reinforced Endotracheal Tube
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Welllead Reinforced Tracheal Tube EUDAMEDReinforced Endotracheal Tube FDA UDI
- Generic Name
- Reinforced endotracheal tube, single-use FDA UDI
- Device Name
- Reinforced Tracheal Tube EUDAMEDReinforced Endotracheal tube (Uncuffed)4.0 FDA UDI
- Model / Reference
- A01E02403F EUDAMEDFDA UDI
- Description
- Reinforced Endotracheal tube (Uncuffed)4.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944932781962 EUDAMEDFDA UDI
- Basic UDI-DI
- 69449327FA01E03CQ EUDAMED
- 510(k) Number
- K073383 FDA UDI
- FDA Product Code
- BTR FDA UDI
- EMDN Code
- R01030102 ENDOTRACHEAL TUBES, CUFFLESS, REINFORCED EUDAMED
- GMDN Term
- Reinforced 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: Reinforced endotracheal tube, single-use
Reinforced Endotracheal Tube 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 Reinforced endotracheal tube, single-use.
- Rurka intubacyjna bez mankietu — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
- Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
- Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- cuff — Contec Medical Systems Co., Ltd. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
Cleared under the same submission
K073383 also covers:
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
- Forsure — FORSURE MEDICAL PRODUCTS LLC
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 5d3e98b6-8d9d-4bff-ab58-74a353325611 34 fields · synced Jun 18, 2026
- EUDAMED a80fab31-eac6-496e-ba8d-77bd7f2c5395 61 fields · synced Jun 18, 2026