Burnshield BUREBK-1-SRB

GUDID 00860011333104

Burn kit with assorted burn dressings, scissors, and gauze in a small red bag.

Burnshield Usa, LLC

Burn kit, non-medicated

• Primary Device ID: 00860011333104
• NIH Device Record Key: e451be7f-4fbc-4dd2-aef2-f4b80445df51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burnshield
• Version Model Number: BUREBK-1-SRB
• Catalog Number: BUREBK-1-SRB
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011333104 [Primary]
GS1	00860011333111 [Package]; Package: CASE [10 Units]; In Commercial Distribution

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: 2023-12-21
• Device Publish Date: 2023-12-13

On-Brand Devices [Burnshield]

• 10198168620998: Burnshield Large Burn Kit - BUREBK-3-RB
• 00860011333104: Burn kit with assorted burn dressings, scissors, and gauze in a small red bag.