Tourni-Cot – Universal
Tourni-Cot - Universal: 1 catalogue number listed by MAR-MED Inc., United States, under Tourniquet, Nonpneumatic. 124 manufacturers in China are registered for this product 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 | MAR-MED Inc., United States |
|---|---|
| FDA product code | GAX |
| Device type | Tourniquet, Nonpneumatic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Manufacturer |
| 510(k) | K853472 |
| Record published | 2020-09-23 |
| Record revised | 2025-01-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Box of 20, inner pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCU | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| MAR-MED Inc. | 510(k) number | 2020-12-28 | Class II | Device Design | A failure can occur if the user attempts to remove the device by partially snipping the edge and pulling on it. The device may tear into two pieces with a portion remaining in place, which can continue to constrict the vessels. This type of | 52,000 | 2023-09-14 |
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.