SAM XT Extremity Tourniquet
SAM XT Extremity Tourniquet - HI-VIZ Orange PW
124manufacturers in China registered for this device type
6catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (47), Jiangsu (26), Guangdong (16). 13 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 |
| Zhejiang Hongyu Medical Commodity Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 36 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Hangzhou Aosi Healthcare Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 18 |
| Nantong City Yojo Medical Products Co., Ltd. | Haimen | Jiangsu | Contract manufacturer | 14 |
| Jiangsu Senolo Medical Technology Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 12 |
| Vistar Medical Supplies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Wenzhou Dongfang Medical Instruments Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 124. All 124 manufacturers in China registered for Tourniquet, Nonpneumatic
Record
| Listed by | SAM Medical Products, United States |
|---|---|
| FDA product code | GAX |
| Device type | Tourniquet, Nonpneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-01 |
| Record revised | 2024-08-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XT600-BK-EN | In distribution | |
| XT700-BL-EN | In distribution | |
| XT700-OR-EN | In distribution | |
| XT600-BL-EN | In distribution | |
| XT700-BK-EN | In distribution | |
| XT600-OR-EN | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rhino Rescue | Wuxi Emsrun Technology Co., Ltd. | 55 |
| FCP Bandage | First Care Products Ltd. | 39 |
| NAR | North American Rescue, LLC. | 39 |
| Bioseal Inc. | Bioseal | 36 |
| Cardinal Health | Cardinal Health 200, LLC | 29 |
| DeRoyal | Deroyal Industries, Inc. | 28 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 25 |
| ASP Medical | ASP Global, LLC | 20 |
| MedSource Tourniquet | Medsource International, LLC | 17 |
| Marketlab | Marketlab Incorporated | 16 |
| Medical Action Industries | Medical Action Industries, Inc. | 16 |
| Novaplus | ASP Global, LLC | 15 |
Showing 12 of 171. All products under Tourniquet, Nonpneumatic
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 | Closed |
|---|---|---|---|---|
| 2018-05-02 | Class II | Employee error | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance th | 2020-07-01 |
| 2018-05-02 | Class II | Employee error | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance th | 2020-07-01 |
| 2018-05-02 | Class II | Employee error | Based on internal testing, results indicated a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. There is a remote chance th | 2020-07-01 |
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.