DeRoyal
ST. Burn KIT Adult Medium
3manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OJJ |
| Device type | Burn Kit Without Drug |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4022 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 8, case of 20, case of 4, case of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10-6541 | In distribution | |
| 10-931 | In distribution | |
| 10-928 | In distribution | |
| 10-1215 | In distribution | |
| 10-930 | In distribution | |
| 10-929 | In distribution | |
| 10-6540 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 517 |
| Medline Industries, Inc. | Medline Industries, Inc. | 142 |
| ACS | American Contract Systems, Inc. | 26 |
| Regard™ | ROi CPS LLC | 10 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 3 |
| Burnshield | Burnshield Usa, LLC | 2 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 2 |
| First Responder Industrial Welding Burn Kit 5/Case | Safeguard US Operating, LLC | 2 |
| Burn Dressing Large – Red Velcro Bag | Certified Safety Manufacturing, Inc. | 1 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 1 |
| BurnFree Burn Kit 10/Case | Safeguard US Operating, LLC | 1 |
Showing 12 of 18. All products under Burn Kit Without Drug
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.