| Primary Device ID | 10198168620998 |
| NIH Device Record Key | 3dd24897-a665-4b41-94f8-f5f768fad8b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Burnshield |
| Version Model Number | BUREBK-3-RB |
| Catalog Number | BUREBK-3-RB |
| Company DUNS | 066750751 |
| Company Name | Burnshield Usa, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com | |
| Phone | 9177272359 |
| info@burnshieldusa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00198168620991 [Primary] |
| GS1 | 10198168620998 [Package] Contains: 00198168620991 Package: CASE [5 Units] In Commercial Distribution |
| OJJ | Burn Kit Without Drug |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-29 |
| Device Publish Date | 2023-11-21 |
| 10198168620998 | Burnshield Large Burn Kit - BUREBK-3-RB |
| 00860011333104 | Burn kit with assorted burn dressings, scissors, and gauze in a small red bag. |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BURNSHIELD 87262226 5399210 Live/Registered |
Levtrade International (Pty) Ltd 2016-12-08 |
![]() BURNSHIELD 86616015 not registered Dead/Abandoned |
Natureplex, LLC 2015-04-30 |
![]() BURNSHIELD 74213418 not registered Dead/Abandoned |
Levtrade International (PTY) Ltd. 1991-10-16 |