Burnshield
Burn kit with assorted burn dressings, scissors, and gauze in a small red bag.
3manufacturers in China registered for this device type
2catalogue 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 | Burnshield Usa, LLC |
|---|---|
| FDA product code | OJJ |
| Device type | Burn Kit Without Drug |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4022 |
| Premarket notification | Exempt |
| Record published | 2023-12-13 |
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, manufacturing date |
| Packaging | Case of 10, case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BUREBK-1-SRB | In distribution | |
| BUREBK-3-RB | 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 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 3 |
| 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.