Portex
11 catalogue numbers from 198-37L, listed by ICU Medical, Inc, United States, under Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector). 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | ICU Medical, Inc, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K953483 |
| Record published | 2015-09-01 |
| Record revised | 2025-04-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box, case of 8 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 198-37L | In distribution | |
| 198-32L | In distribution | |
| 197-41R | In distribution | |
| 198-39L | In distribution | |
| 198-28L | In distribution | |
| 198-35L | In distribution | |
| 197-35R | In distribution | |
| 197-32R | In distribution | |
| 197-39R | In distribution | |
| 197-37R | In distribution | |
| 197-28R | 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 |
| Arndt | Cook Incorporated | 9 |
Showing 12 of 29. All products under Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
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.