Forsure
A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and…
A hollow cylinder that is designed for oral insertion via the trachea and into a lung to maintain airway patency and/or to deliver anaesthetic inhalation agents or other medical gases, and secure ventilation. It is typically made of plastic, rubber, or silicone and may be packaged with a connector that attaches to a breathing circuit and is available in two basic configurations: 1) a double lumen tube with independent cuffs at the distal end for ventilation of the left or right bronchi; or 2) a twin lumen tube with independent cuffs for selective lung ventilation during thoracic surgery or postoperative care when independent lung ventilation is indicated. This is a single-use device.
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 | Forsure Medical Products LLC., 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 |
| Establishment | Repacker / relabeller |
| 510(k) | K092886 |
| Record published | 2017-10-30 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: STORE IN DRY CONDITIONS AWAY FROM HEAT AND LIGHT |
| Packaging | Master case of 20, inner box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11230037 | In distribution | |
| 11220039 | Fr 39, Cuffed, Left | In distribution |
| 11220028 | 28 Fr, Cuffed, Left | In distribution |
| 11220037 | 37 Fr, Cuffed, Left | In distribution |
| 11220032 | 32 Fr, Cuffed, Left | In distribution |
| 11230039 | 39Fr, Cuffed, Right | In distribution |
| 11230028 | 28Fr, Cuffed, Right | In distribution |
| 11230041 | 41Fr, Cuffed, Right | In distribution |
| 11220035 | 35 Fr, Cuffed, Left | In distribution |
| 11220041 | Fr 41, Cuffed Left | In distribution |
| 11230035 | 35Fr, Cuffed, Right | In distribution |
| 11230032 | 32Fr, Cuffed, Right | 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 |
| 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)
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Parker Medical | 510(k) number | 2016-12-16 | Class II | Under Investigation by firm | The product was not functioning as intended. The ventilation to the patient was not disrupted, but the single lung isolation and ventilation did not function as intended. | 1,060 units | 2017-04-17 |
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.