HI-VIS Emergency Blanket 04-106

GUDID M68904106020

The HI-VIS Emergency Blanket provide a passive remedy to help manage hypothermia in emergency situations. This device will utilize the patient’s body heat to try and preserve the core body temperature.

Safeguard US Operating, LLC

Hypothermia-prevention whole-body suit

• Primary Device ID: M68904106020
• NIH Device Record Key: cc37decf-f6a1-443f-ae5f-41f80becd7c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HI-VIS Emergency Blanket
• Version Model Number: 02
• Catalog Number: 04-106
• Company DUNS: 118492643
• Company Name: Safeguard US Operating, 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: false
• 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
HIBCC	M68904106020 [Primary]

FDA Product Code

• KME: Bedding, Disposable, Medical

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: 2025-09-23
• Device Publish Date: 2025-09-15

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