Bioseal Inc.
Trach Tape
46manufacturers in China registered for this device type
14catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (12), Zhejiang (12), Guangdong (9). 16 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 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Dongguan Shin YI Healthcare Products Factory | Dong Guan | Guangdong | Contract manufacturer | 30 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
Showing 12 of 46. All 46 manufacturers in China registered for Device, Fixation, Tracheal Tube
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | CBH |
| Device type | Device, Fixation, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5770 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 72, case of 24, case of 36 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6510NS/72 | In distribution | |
| 6591/72 | In distribution | |
| 6653/72 | In distribution | |
| 6511/72 | In distribution | |
| 6628/72 | In distribution | |
| 6663/72 | In distribution | |
| 6524/72 | In distribution | |
| 6513/72 | In distribution | |
| 6524/24 | In distribution | |
| 6450RG/36 | In distribution | |
| 6552/72 | In distribution | |
| 6460/72 | In distribution | |
| 6652/72 | In distribution | |
| 6512/72 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EZCare™ Softouch | Neotech Products, LLC | 31 |
| Marpac Inc | Marpac, Inc. | 29 |
| Trach Tie | Pepper Medical, Inc. | 27 |
| Tracoe care | Tracoe Medical Gmbh | 15 |
| Dr Zee | Resp Devices LLC | 14 |
| NeoBar® | Neotech Products, LLC | 14 |
| ProCure | Twin Med, LLC | 13 |
| Hudson RCI | Teleflex Medical LLC | 11 |
| Vent Tie | Pepper Medical, Inc. | 10 |
| Medline | Medline Industries, Inc. | 9 |
| Posey | Posey Products, LLC | 8 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
Showing 12 of 123. All products under Device, Fixation, Tracheal Tube
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K882694 | 1988-08-15 |
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.