Ellman-Cot
COTS-LARGE-12 PCS Digit Tourniquet(Blue)
2manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Caremax Co., Ltd. | Suzhou, Jiangsu Province | Contract manufacturer | 17 |
Record
| Listed by | Cynosure, LLC, United States |
|---|---|
| FDA product code | OJS |
| Device type | Tourniquet Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-01-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H99 | 12 | In distribution | |
| H97 | 12 | In distribution | |
| H98 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaplex | Bound Tree Medical, LLC | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| Direct IV Solutions – IV Start Kit | Lynn Medical Instrument Co | 4 |
| Argyle | Cardinal Health | 4 |
| SAM Bleeding Control Kit | SAM Medical Products | 2 |
| Argyle | Cardinal Health 200, LLC | 1 |
| Ellman Cots | Cynosure, LLC | 1 |
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.