Hudson RCI
ET Tube, Sher-I-Bronch, RS, 37 FR
4manufacturers in China registered for this device type
21catalogue 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) | K180253 |
| Record published | 2018-09-20 |
| Record revised | 2025-09-26 (version 24) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: None; Storage environment temperature 32 to 122 °F |
| Packaging | Box, case of 4 |
| Sizes | Length 15 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN049001 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044857 | Length 15 mm | In distribution |
| IPN044855 | Length 15 mm | In distribution |
| IPN044858 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044861 | Length 15 mm | In distribution |
| IPN044854 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044863 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044860 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN048995 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044856 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN048993 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN049002 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN048997 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN048999 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044862 | Length 15 mm | In distribution |
| IPN048994 | Sher-I-Bronch Endobronchial Tube | In distribution |
| 5-16137 | In distribution | |
| IPN048998 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN044859 | Length 15 mm | In distribution |
| IPN049000 | Sher-I-Bronch Endobronchial Tube | In distribution |
| IPN048996 | Sher-I-Bronch Endobronchial Tube | 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 |
| 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 Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2019-10-30 | Class II | Process control | The tracheal and brochial swivel connectors are incorrectly labeled. | 53 units | 2021-09-30 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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 |
| Teleflex Medical LLC | 510(k) number | 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 | |
| Teleflex Medical LLC | 510(k) number | 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 |
Recalls
2 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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 |
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.