AnchorFast Guard
2 catalogue numbers from 9800, listed by Hollister Incorporated, United States, under Device, Fixation, Tracheal Tube. 46 manufacturers in China are registered for this product code.
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 | Hollister Incorporated, United States |
|---|---|
| FDA product code | CBH |
| Device type | Device, Fixation, Tracheal Tube |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5770 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
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, expiry date |
| Packaging | Cas, case |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9800 | 12 | In distribution | |
| 9800 | 12 | 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 |
| Medline | Medline Industries, Inc. | 9 |
| Posey | Posey Products, LLC | 8 |
Showing 12 of 123. All products under Device, Fixation, 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 |
|---|---|---|---|---|---|---|
| Hollister Incorporated | UDI-DI | 2024-12-23 | Class II | Process change control | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 4,955 box / 59,460 eaches |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-12-23 | Class II | Process change control | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 701 box / 8,412 eaches |
| 2024-12-23 | Class II | Process change control | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 30,527 box / 366,324 eaches |
| 2024-12-23 | Class II | Process change control | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 45 box / 540 eaches |
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.