SAM Bleeding Control Kit
Bleeding Control KIT Basic-Vaccum Seal
2manufacturers in China registered for this device type
2catalogue 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 | SAM Medical Products, United States |
|---|---|
| FDA product code | OJS |
| Device type | Tourniquet Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5900 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KT901-NV-EN | In distribution | |
| KT901-V-EN | 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 |
| Ellman-Cot | Cynosure, LLC | 3 |
| 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.