Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
The Endobronchial Tube is a differential ventilation tube used to isolate the left or right lung for surgery. The FDA filing directly lists Fr26 as a size option. This submission identifies…
The Endobronchial Tube is a differential ventilation tube used to isolate the left or right lung for surgery. The FDA filing directly lists Fr26 as a size option.
This submission identifies left and right versions, each with a range of French sizes. The listed Right:Fr26 item matches one of the named right-side sizes.
Listed Item
The Endobronchial tube contians 1Pc Fr33 Right Endobronchial tube,1Pc Multifunctional joint and 2Pcs Fr10 Suction catheter, 1Pc Fr16 Suction catheter.
Device Role and Details
The source calls the device an endobronchial double-lumen tube and gives its FDA classification as a tracheal or bronchial differential ventilation tube.
For its stated role, the tube is placed to separate ventilation between the lungs during surgery, according to the filing’s intended-use description.
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 | Henan Tuoren Medical Device 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 |
| 510(k) | K152251 |
| Record published | 2019-10-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 26 to 41 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Left:Fr41 | Catheter Gauge 41 Fr | In distribution |
| Left:Fr31 | Catheter Gauge 31 Fr | In distribution |
| Right:Fr35 | Catheter Gauge 35 Fr | In distribution |
| Left:Fr28 | Catheter Gauge 28 Fr | In distribution |
| Left:Fr33 | Catheter Gauge 33 Fr | In distribution |
| Right: Fr32 | Catheter Gauge 32 Fr | In distribution |
| Right: Fr31 | Catheter Gauge 31 Fr | In distribution |
| Right:Fr26 | Catheter Gauge 26 Fr | In distribution |
| Right:Fr33 | Catheter Gauge 33 Fr | In distribution |
| Right:Fr37 | Catheter Gauge 37 Fr | In distribution |
| Left:Fr32 | Catheter Gauge 32 Fr | In distribution |
| Left:Fr35 | Catheter Gauge 35 Fr | In distribution |
| Left:Fr37 | Catheter Gauge 37 Fr | In distribution |
| Right: Fr41 | Catheter Gauge 41 Fr | In distribution |
| Right: Fr39 | Catheter Gauge 39 Fr | In distribution |
| Left:Fr39 | Catheter Gauge 39 Fr | In distribution |
| Left:Fr26 | Catheter Gauge 26 Fr | In distribution |
| Right:Fr28 | Catheter Gauge 28 Fr | 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 |
| Parker Flex-Tip | Salter Labs | 18 |
| Parker | Salter Labs | 17 |
| Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | Hangzhou Tappa Medical Technology Co., Ltd. | 12 |
| 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 |
|---|---|
| K152251 | 2016-06-10 |
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.