VivaSight™ 2 DLT Kit 37 Fr – Left
VivaSight 2 DLT Kit 37 Fr - LEFT
4manufacturers in China registered for this device type
1catalogue number
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 | Ambu A/S, Denmark |
|---|---|
| FDA product code | CBI |
| Device type | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5740 |
| Establishment | Specification developer, Private-label distributor, Manufacturer, Exporter |
| Record published | 2021-06-25 |
| Record revised | 2026-01-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 25 °C; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH |
| Packaging | Pack of 5 |
| Sizes | Lumen/inner diameter 4.6 mm; outer diameter 11 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 412371000 | Adult | 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 |
|---|---|
| K203749 | 2021-05-03 |
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.