TRI-FLO™
Subglotic Suction System
Who Else Makes It
Concentrated in Zhejiang (29), Guangdong (28), Jiangsu (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
Showing 12 of 93. All 93 manufacturers in China registered for Catheters, Suction, Tracheobronchial
Record
| Listed by | Vyaire Medical, Inc., United States |
|---|---|
| FDA product code | BSY |
| Device type | Catheters, Suction, Tracheobronchial |
| Device class | Class 1 |
| Regulation | 21 CFR 868.6810 |
| Premarket notification | Exempt |
| Record published | 2019-12-20 |
| Record revised | 2020-04-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TF28010 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ballard™ | SunMed Group Holdings, LLC | 214 |
| Res-Q-Vac | Repro-Med Systems, Inc. | 201 |
| DAR | Covidien LP | 185 |
| Ballard* Closed Suction System for Adults | Avanos Medical, Inc. | 108 |
| Suction Catheter | Well Lead Medical Co., Ltd. | 97 |
| Avanos | Avanos Medical, Inc. | 63 |
| Ballard* Closed Suction System | Avanos Medical, Inc. | 57 |
| Ballard* Turbo-Cleaning Closed Suction System | Avanos Medical, Inc. | 57 |
| Medline | Medline Industries, Inc. | 49 |
| ProCure | Twin Med, LLC | 47 |
| AirLife™ | Airlife, Inc. | 44 |
| Closed Suction Catheters | Ningbo Xinwell Medical Technology Co., Ltd. | 38 |
Showing 12 of 147. All products under Catheters, Suction, Tracheobronchial
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-06-20 | Class I | Process control | Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and res | 2150 Units Total | 2020-07-28 |
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.