Bivona
37 catalogue numbers from BV1027, listed by ICU Medical, Inc, United States, under Tube, Tracheostomy (W/Wo Connector). 1 manufacturer in China is registered for this product code.
1manufacturer
37catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K810436 |
| Record published | 2015-09-01 |
| Record revised | 2025-04-24 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BV1027 | In distribution | |
| 60P035 | In distribution | |
| BV0927 | In distribution | |
| R60P030 | In distribution | |
| R60P040 | In distribution | |
| BV0936 | In distribution | |
| R60N030 | In distribution | |
| 855180 | In distribution | |
| 60N025 | In distribution | |
| 60SP040 | In distribution | |
| BV1036 | In distribution | |
| 60SN035 | In distribution | |
| BV0918 | In distribution | |
| 60SN030 | In distribution | |
| R60P050 | In distribution | |
| R60N025 | In distribution | |
| 855170 | In distribution | |
| 60SP050 | In distribution | |
| BV0818 | In distribution | |
| BV1236 | In distribution | |
| 60SN040 | In distribution | |
| 60SP045 | In distribution | |
| 60SP025 | In distribution | |
| 60P040 | In distribution | |
| BV0836 | In distribution | |
| BV1018 | In distribution | |
| BV1055 | In distribution | |
| 60P030 | In distribution | |
| BV0955 | In distribution | |
| 60N035 | In distribution | |
| BV1255 | In distribution | |
| 60SN025 | In distribution | |
| 60P025 | In distribution | |
| BV1227 | In distribution | |
| BV1436 | In distribution | |
| BV0855 | In distribution | |
| BV0827 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tracoe® comfort | Tracoe Medical Gmbh | 1,296 |
| Portex | ICU Medical, Inc | 380 |
| Pilling | Teleflex Medical LLC | 248 |
| Premier | Premier Dental Products Co. | 111 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
Recalls Naming This Product
47 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 |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | 177340 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | 25283 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | 3138 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | 36219 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2024-05-29 | Class I | Under Investigation by firm | Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect. | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2023-08-22 | Class II | Labeling mix-ups | The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026). | ||
| Smiths Medical Asd, Inc. | 510(k) number | 2020-08-28 | Class II | Error in labeling | Label has the incorrect size for the tracheotomy tube. | 3 units | 2021-05-13 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-02-09 | Class II | Labeling False and Misleading | Smiths Medical became aware that one lot of the Bivona 3.5mm TTS Cuffed Pediatric tracheostomy tubes was incorrectly labeled for neonatal use instead of correctly labeled for pediatric use. | 142 | 2018-06-20 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
| Smiths Medical Asd, Inc. | 510(k) number | 2011-11-28 | Not classified | Device Design | Difficulty disconnecting accessories from the Bivona Uncuffed Neonatal, Pediatric and Flextend Tracheostomy Tubes TR3 connector, which may result in a delay in initiating therapy or patient discomfort. If excessive force is used to detach | US distribution 153,033 devices ; Foreign 21,490 devices | 2014-10-17 |
Showing 40 of 47.
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.