Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
The Endobronchial Blocker Tube is a differential ventilation tube intended to enter a bronchus and isolate one lung during procedures requiring one-lung ventilation. The FDA packet names…
The Endobronchial Blocker Tube is a differential ventilation tube intended to enter a bronchus and isolate one lung during procedures requiring one-lung ventilation.
The FDA packet names the EBT model family, including the listed EBT0205S and EBT0207S variants. Its described purpose is bronchial isolation for one-lung ventilation.
Device Role and Details
This function is described for surgical procedures that require one-lung ventilation. The tube acts at the bronchus so the left or right lung can be isolated.
The filing distinguishes a 5Fr version for pediatric patients of at least 10 kg from other sizes, which it identifies for adult use.
Who Else Makes It
Concentrated in Guangdong (2), Henan (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Henan Tuoren Medical Device Co., Ltd. | Changyuan | Henan | Manufacturer | 5 |
| Hangzhou Tappa Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Hangzhou Tappa Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | CBI |
| Device type | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5740 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K251950 |
| Record published | 2026-06-26 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Inner box, outer carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EBT0205 | In distribution | |
| EBT0107S | In distribution | |
| EBT0205S | In distribution | |
| EBT0207 | In distribution | |
| EBT0209S | In distribution | |
| EBT0105 | In distribution | |
| EBT0107 | In distribution | |
| EBT0207S | In distribution | |
| EBT0109S | In distribution | |
| EBT0109 | In distribution | |
| EBT0209 | In distribution | |
| EBT0105S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Insighters | Shenzhen Insighters Medical Technology Co., Ltd. | 39 |
| Rusch | Teleflex Medical LLC | 26 |
| Univent Tube (TCB Type) | Fuji Systems Corp. | 22 |
| Hudson RCI | Teleflex Medical LLC | 21 |
| Sheridan | Teleflex Medical LLC | 19 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Henan Tuoren Medical Device Co., Ltd. | 18 |
| Parker Flex-Tip | Salter Labs | 18 |
| Parker | Salter Labs | 17 |
| Forsure | Forsure Medical Products LLC. | 12 |
| Endobronchial Tube | Well Lead Medical Co., Ltd. | 12 |
| Portex | ICU Medical, Inc | 11 |
| Arndt | Cook Incorporated | 9 |
Showing 12 of 29. All products under Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251950 | 2026-03-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.