BurnFree Burn Kit 10/Case SBK-12.00.000

GUDID M689SBK1200000030

This 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.

Safeguard US Operating, LLC

Burn kit, non-medicated

• 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

Customer Support Contacts

• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com
• Phone: 855-428-6074
• Email: sales@safeguardmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M689SBK1200000030 [Primary]

FDA Product Code

• OJJ: Burn Kit Without Drug

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-13
• Device Publish Date: 2026-02-05

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