Medline
Ettub Fastenr Mbrace, 4PT Strap, BIT BLK
46manufacturers in China registered for this device type
9catalogue numbers in this listing
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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | CBH |
| Device type | Device, Fixation, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5770 |
| Premarket notification | Exempt |
| Record published | 2024-08-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Keep away from sunlight, Keep Dry. |
| Packaging | Box of 10, case of 12, box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYN597L | In distribution | |
| DYN540 | In distribution | |
| DYN541 | In distribution | |
| DYN597M | In distribution | |
| DYNJMBRC2 | In distribution | |
| ZPP301P | In distribution | |
| DYN542 | In distribution | |
| DYN597S | In distribution | |
| DYNJMBRC4B | 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 |
| Bioseal Inc. | Bioseal | 14 |
| ProCure | Twin Med, LLC | 13 |
| Hudson RCI | Teleflex Medical LLC | 11 |
| Vent Tie | Pepper Medical, Inc. | 10 |
| Posey | Posey Products, LLC | 8 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
Showing 12 of 123. All products under Device, Fixation, Tracheal Tube
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-18 | Class II | Nonconforming Material/Component | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient’s cheekbones and upper lip which may cause dermal injury depending on the device position | 1332 units |
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-18 | Class II | Nonconforming Material/Component | Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient’s cheekbones and upper lip which may cause dermal injury depending on the device position | 768 units |
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.