Home › Device types › CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
FDA product code CBI · Class 2 · Anesthesiology
297
Registered devices
1,579
Adverse events
10
Recalls
34
510(k) clearances
Devices with this code
Forsure — FORSURE MEDICAL PRODUCTS LLCUNIVENT TUBE (TCB TYPE) — FUJI SYSTEMS CORPORATIONSHERIDAN — TELEFLEX INCORPORATEDPortex — ICU MEDICAL, INC.RUSCH — TELEFLEX INCORPORATEDSHERIDAN — TELEFLEX INCORPORATEDUNIVENT TUBE (TCB TYPE) — FUJI SYSTEMS CORPORATIONUNIBLOCKER — FUJI SYSTEMS CORPORATIONHUDSON RCI — TELEFLEX INCORPORATEDInsighters — Shenzhen Insighters Medical Technology Co., Ltd.SILBRONCHO (LEFT LUNG) — FUJI SYSTEMS CORPORATIONSHERIDAN — TELEFLEX INCORPORATEDNA — Henan Tuoren Medical Device Co.,Ltd.Endobronchial Tube — Well Lead Medical Co.,LtdSHERIDAN — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATEDRUSCH — TELEFLEX INCORPORATEDSILBRONCHO (RIGHT LUNG) — FUJI SYSTEMS CORPORATIONUNIVENT TUBE (TCB TYPE) — FUJI SYSTEMS CORPORATIONInsighters — Shenzhen Insighters Medical Technology Co., Ltd.Portex — ICU MEDICAL, INC.HUDSON RCI — TELEFLEX INCORPORATEDUNIVENT TUBE (TCB TYPE) — FUJI SYSTEMS CORPORATIONNA — Hangzhou Tappa Medical Technology Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-16 | Ambu Inc. | Ambu has received complaints on Ambu VivaSight 2 DLTs regarding hyper angulation of the distal end. The hyper angulation can lead to an increased risk of compli |
| 2022-06-03 | Ambu Inc. | Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secu |
| 2019-10-30 | Teleflex Medical | The tracheal and brochial swivel connectors are incorrectly labeled. |
| 2016-12-16 | Parker Medical | 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 a |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2015-06-01 | Teleflex Medical | The double swivel connector may crack or separate on the endobronchial tube. |
| 2005-02-23 | Teleflex Medical | 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 |
| 2005-02-23 | Teleflex Medical | 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.