Uniblocker
UNIBLOCKER is intended for one-lung ventilation for endobronchial blockade of the left or right lung in thoracic surgery, lung resection, VATS, lobectomy, etc.
4manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance
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 | Fuji Systems Corp., United States |
|---|---|
| FDA product code | CBI |
| Device type | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5740 |
| 510(k) | K894337 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9.0FR | In distribution | |
| 5.0FR | In distribution | |
| 9.0FR | In distribution | |
| 5.0FR | 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 |
| 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 |
Showing 12 of 29. All products under Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051522 | 2005-08-17 |
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.