Argyle
Vascular Tourniquet Retractor
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 | Cardinal Health, United States |
|---|---|
| FDA product code | OJS |
| Device type | Tourniquet Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-29 |
| Record revised | 2025-11-20 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Storage | Special storage condition: none; |
| Packaging | Case of 10 |
| Sizes | Length 5 in |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8888585000 | Withdrawn | ||
| 5558585021 | 2,500 | Withdrawn | |
| 5558585005 | Length 5 in | 100 | Withdrawn |
| 5558585047 | 1,500 | Withdrawn |
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 |
| 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.