Data / Medical devices / Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) (CBI): 23 FDA-registered makers in 9 countries
23 establishments in 9 countries are registered with the FDA to make Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) (product code CBI, Class 2, 21 CFR 868.5740). 22 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on March 20, 2026, and lists 6 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- CBI
- Device class
- 2
- Regulation
- 868.5740
- Medical specialty
- Anesthesiology
- Life sustaining or supporting
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| China | 4 |
| Mexico | 3 |
| Japan | 2 |
| Czechia | 2 |
| Malaysia | 2 |
| Ireland | 1 |
| Denmark | 1 |
| South Korea | 1 |
Makers of Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 7 | November 2, 2018 | 0 | 2 | 1 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 4 | August 2, 2016 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 4 | November 2, 2018 | 0 | 0 | 0 | api.fda.gov |
| PULMONX, Corp. | Redwood City, CA, United States | Complaint file establishment, Manufacturer | 3 | February 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant | Shirakawa Fukushima, Japan | Manufacturer | 2 | August 17, 2005 | 0 | 0 | 0 | api.fda.gov |
| FUJI SYSTEMS CORPORATION, Shirakawa Plant | Nishi Shirakawa Gun Fukushima, Japan | Manufacturer | 2 | August 17, 2005 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 2 | May 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical | ATHLONE Westmeath, Ireland | Manufacturer, Specification developer | 2 | April 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Ambu A/S | Ballerup Hovedstaden, Denmark | Specification developer | 1 | May 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Arrow International C.R. a.s. | ZDAR NAD SAZAVOU Vysocina, Czechia | Manufacturer | 1 | September 28, 2012 | 0 | 0 | 0 | api.fda.gov |
| Arrow International CR, a.s. | Hradec Kralove, Czechia | Manufacturer | 1 | September 28, 2012 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Ciudad Juarez Chihuahua, Mexico | Manufacturer | 1 | March 26, 1993 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 1 | March 26, 1993 | 0 | 0 | 0 | api.fda.gov |
| Henan Tuoren Medical Device Co., Ltd. | Changyuan Henan, China | Manufacturer | 1 | June 10, 2016 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Tappa Medical Technology Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 1 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | October 24, 1995 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | October 24, 1995 | 0 | 0 | 0 | api.fda.gov |
| Insung Medical Co., Ltd. | WONJU-SI Gangwon, South Korea | Manufacturer | 1 | December 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Salter Labs | El Paso, TX, United States | Complaint file establishment, Specification developer | 1 | March 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 1 | March 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical Sdn. Bhd. | KAMUNTING Perak, Malaysia | Manufacturer | 1 | April 15, 2015 | 0 | 0 | 0 | api.fda.gov |
| Well Lead Medical Co. Ltd | GUANGZHOU Guangdong, China | Contract manufacturer, Manufacturer | 1 | March 11, 2010 | 0 | 0 | 0 | api.fda.gov |
| Ambu SDN.BHD. | PENANG Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated March 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.