Centurion
Sterile Trach Brush
26manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (9), Guangdong (6), Zhejiang (5). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shanghai Like Brush Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
Showing 12 of 26. All 26 manufacturers in China registered for Brush, Cleaning, Tracheal Tube
Record
| Listed by | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | EPE |
| Device type | Brush, Cleaning, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5795 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6225ST | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| InHealth Technologies; Blom-Singer; Classic | Freudenberg Medical, LLC | 37 |
| Tracoe® care | Tracoe Medical Gmbh | 9 |
| InHealth Technologies; Blom-Singer; Advantage | Freudenberg Medical, LLC | 9 |
| Trach Tube Cleaning Brushes | Boston Medical Products, Inc. | 8 |
| InHealth Technologies; Blom-Singer; Dual Valve | Freudenberg Medical, LLC | 6 |
| Grafco | GF Health Products, Inc | 4 |
| Pilling | Teleflex Medical LLC | 4 |
| InHealth Technologies; Blom-Singer | Freudenberg Medical, LLC | 3 |
| XinjingProWellness™ | Tianjin Newtrans Technology Development | 3 |
| Sklar | Sklar Corporation | 3 |
| AincA® | Anesthesia Associates, Inc. | 3 |
| Bioseal Inc. | Bioseal | 2 |
Showing 12 of 29. All products under Brush, Cleaning, Tracheal Tube
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 1700 |
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.