Hypothermia Management Set - Bag (GR) and Grid (8 cell) 59-110

GUDID M68959110010

This device is intended for use on adult patients who are at risk of developing or showing the signs and symptoms of hypothermia in the pre-hospital environment. WARNING: Do not place Ready-Heat on exposed skin.

Safeguard US Operating, LLC

Hypothermia-prevention whole-body suit

• Primary Device ID: M68959110010
• NIH Device Record Key: 2857527e-02e7-45dc-8952-8663827a5fc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypothermia Management Set - Bag (GR) and Grid (8 cell)
• Version Model Number: 01
• Catalog Number: 59-110
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68959110010 [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: 2024-09-06
• Device Publish Date: 2024-08-29

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