| Primary Device ID | M689SBK1200000030 |
| NIH Device Record Key | 26d2228a-619a-475a-bfdd-7be51eb2f532 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BurnFree Burn Kit 10/Case |
| Version Model Number | 03 |
| Catalog Number | SBK-12.00.000 |
| Company DUNS | 118492643 |
| Company Name | Safeguard US Operating, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| M689SBK1200000030 - BurnFree Burn Kit 10/Case | 2026-02-13This kit offers a versatile combination of Burn Dressings, Burn Wrap/Fire Blankets and Burn Jel to meet emergency burn care needs in all resource limited settings (RLS) to better meet the different work environments of emergency medical and rescue first responders. It is designed and intended for use by emergency medical, rescue and non-medical personnel. |
| M689SBK1200000030 - BurnFree Burn Kit 10/Case | 2026-02-13 This kit offers a versatile combination of Burn Dressings, Burn Wrap/Fire Blankets and Burn Jel to meet emergency burn care need |
| M68985201020 - Mojo Vehicle Rescue Bag - Basic | 2026-02-09 This device is apart of the Mojo Aid and Litter Systems. It is a minimal cube and weight solutions intended to be vehicle born |
| M6898810301020 - Pocket Trauma Kit Basic | 2026-02-09 First Responder kits are intended to be carried and used by dedicated non-medical First Responders. Vacuum-seal trauma treatmen |
| M6898810304020 - Pocket Trauma Kit | 2026-02-09 First Responder kits are intended to be carried and used by dedicated non-medical First Responders. Vacuum-seal trauma treatmen |
| M68980820120 - Valkyrie LTOWB Collection Set | 2026-01-30 This convenience kit is intended to be used by trained and credentialed individuals to treat blood loss or to supply blood due t |
| M68980821110 - Valkyrie LTOWB Administration Set | 2026-01-30 This convenience kit is intended to be used by trained and credentialed individuals to treat blood loss or to supply blood due t |
| M68980820110 - Valkyrie LTOWB Collection Set | 2026-01-23 ADVANCED LTOWB COLLECTION SET
Constricting Band (18" x 1") 1 ea
Gauze Sponge 2 ea
Safety IV Ca |
| M68980821100 - Valkyrie LTOWB Administration Set | 2026-01-23 ADVANCED LTOWB ADMINISTRATION SET
Constricting Band (18" x 1") 1 ea
Gauze Sponge 4 ea
Safe |