Bivona
41 catalogue numbers from 35W065, listed by ICU Medical, Inc, United States, under Tube, Tracheal (W/Wo Connector). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
41catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Tianjin Medis Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Chilecom Medical Devices Co Ltd | Xiangtan | Hunan | Manufacturer | 5 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | BTR |
| Device type | Tube, Tracheal (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5730 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K792035 |
| Record published | 2015-09-01 |
| Record revised | 2025-04-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 35W065 | In distribution | |
| 15W075 | In distribution | |
| 35W075 | In distribution | |
| 15W085 | In distribution | |
| 25W095 | In distribution | |
| 15W050 | In distribution | |
| 15W070 | In distribution | |
| 25W060 | In distribution | |
| 35W070 | In distribution | |
| 15W045 | In distribution | |
| 35W080 | In distribution | |
| 35W050 | In distribution | |
| 25W065 | In distribution | |
| 15W080 | In distribution | |
| 35W090 | In distribution | |
| 25W080 | In distribution | |
| 35W055 | In distribution | |
| 15W060 | In distribution | |
| 35W045 | In distribution | |
| 25W085 | In distribution | |
| DRYPORT | In distribution | |
| 35W085 | In distribution | |
| 15W025 | In distribution | |
| 15W030 | In distribution | |
| 15W035 | In distribution | |
| 35W035 | In distribution | |
| 35W040 | In distribution | |
| 15W040 | In distribution | |
| 35W060 | In distribution | |
| 35W095 | In distribution | |
| 25W070 | In distribution | |
| 25W075 | In distribution | |
| 15W090 | In distribution | |
| 25W090 | In distribution | |
| SAT605 | In distribution | |
| 15W055 | In distribution | |
| 35W025 | In distribution | |
| 35W030 | In distribution | |
| 15W065 | In distribution | |
| SAT757 | In distribution | |
| SAT656 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 301 |
| Shiley | Covidien LP | 295 |
| Mallinckrodt | Covidien LP | 258 |
| Hudson RCI | Teleflex Medical LLC | 241 |
| Portex | ICU Medical, Inc | 208 |
| Parker Flex-Tip | Salter Labs | 164 |
| Parker | Salter Labs | 157 |
| Curaplex | Bound Tree Medical, LLC | 149 |
| SourceMark | Sourcemark, LLC. | 148 |
| Montgomery® Safe-T-Tube™ | Boston Medical Products, Inc. | 144 |
| Sunmed | SunMed Group Holdings, LLC | 112 |
| Forsure | Forsure Medical Products LLC. | 101 |
Showing 12 of 374. All products under Tube, Tracheal (W/Wo Connector)
Recalls Naming This Product
2 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 | 2021-08-09 | Class II | Process control | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. | 7136 devices | 2023-10-13 |
| Smiths Medical Asd, Inc. | 510(k) number | 2021-08-09 | Class II | Process control | Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm. | 2191 devices | 2023-10-13 |
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.