DeRoyal
Infant Back Up Tourniquet
2manufacturers in China registered for this device type
4catalogue 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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OJS |
| Device type | Tourniquet Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-03-03 |
| Record revised | 2025-11-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 25, case of 40 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 32-1960 | In distribution | |
| 32-1962 | In distribution | |
| 32-1961 | In distribution | |
| 32-2014 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaplex | Bound Tree Medical, LLC | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
| Direct IV Solutions – IV Start Kit | Lynn Medical Instrument Co | 4 |
| Argyle | Cardinal Health | 4 |
| Ellman-Cot | Cynosure, LLC | 3 |
| 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.