Rusch
Carlens Bronchial Double Lumen Tube SET (Left), Sterile
4manufacturers in China registered for this device type
26catalogue numbers in this listing
1510(k) clearance
7recalls on this code
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 | Teleflex Medical 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K121462 |
| Record published | 2015-10-16 |
| Record revised | 2025-03-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -10 to 40 °C; Handling environment temperature -10 to 40 °C |
| Packaging | Box, case of 24, carton of 56, carton of 5, case of 5 |
| Sizes | Length 280 to 350 mm; catheter gauge 6 to 7 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN046435 | 7F | In distribution |
| IPN041726 | Length 350 mm | In distribution |
| IPN041722 | Length 350 mm | In distribution |
| IPN913391 | In distribution | |
| IPN041702 | Length 330 mm | In distribution |
| IPN041720 | Length 320 mm | In distribution |
| IPN041705 | Length 310 mm | In distribution |
| IPN041718 | Length 280 mm | In distribution |
| IPN041699 | Length 280 mm | In distribution |
| IPN041723 | Length 310 mm | In distribution |
| IPN041703 | Length 340 mm | In distribution |
| IPN041698 | Length 280 mm | In distribution |
| IPN041725 | Length 340 mm | In distribution |
| IPN044218 | Catheter Gauge 6 Fr | In distribution |
| IPN041700 | Length 300 mm | In distribution |
| IPN041706 | Length 330 mm | In distribution |
| IPN926248 | In distribution | |
| IPN044219 | Catheter Gauge 6 Fr | In distribution |
| IPN041701 | Length 310 mm | In distribution |
| IPN041717 | Length 280 mm | In distribution |
| IPN044217 | Ch.6 | In distribution |
| IPN041721 | Length 340 mm | In distribution |
| IPN041724 | Length 320 mm | In distribution |
| IPN041719 | Length 310 mm | In distribution |
| IPN041707 | Length 340 mm | In distribution |
| IPN041704 | Length 300 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Insighters | Shenzhen Insighters Medical Technology Co., Ltd. | 39 |
| 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 |
| 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 |
|---|---|
| K180253 | 2018-11-02 |
Recalls
4 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-10-30 | Class II | Process control | The tracheal and brochial swivel connectors are incorrectly labeled. | 53 units | 2021-09-30 |
| 2015-06-01 | Class I | Unknown/Undetermined by firm | The double swivel connector may crack or separate on the endobronchial tube. | 188,195 total units | 2018-04-16 |
| 2015-06-01 | Class I | Unknown/Undetermined by firm | The double swivel connector may crack or separate on the endobronchial tube. | 188,195 total units | 2018-04-16 |
| 2015-06-01 | Class I | Unknown/Undetermined by firm | The double swivel connector may crack or separate on the endobronchial tube. | 188,195 total units | 2018-04-16 |
| 2015-06-01 | Class I | Unknown/Undetermined by firm | The double swivel connector may crack or separate on the endobronchial tube. | 188,195 total units | 2018-04-16 |
| 2005-02-23 | Not classified | Other | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating ‘Bronchial – Right’ instead of ‘Bronchial – Left’, and catalog number 5-16137 stating ‘Bronchial – Left’ instead of ‘Bronchial – Right’ | 2006-07-31 | |
| 2005-02-23 | Not classified | Other | The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating ‘Bronchial – Right’ instead of ‘Bronchial – Left’, and catalog number 5-16137 stating ‘Bronchial – Left’ instead of ‘Bronchial – Right’ | 2006-07-31 |
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.