HELIOS System HELIOS-KW

GUDID 00818630010463

Casualty hypothermia prevention and management system with active warming for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty with an active warming heat pack. Blanket anchors can be secured to most litters to reduce exposure from rotor wash and high winds. A high visibility pocket is located in the center for placement of STAT cards or other triage cards. Each blanket is 46" x 94".

TACTICAL MEDICAL SOLUTIONS, LLC

Hypothermia-prevention whole-body suit

• Primary Device ID: 00818630010463
• NIH Device Record Key: 9b130695-188f-494a-a82d-8a8744c8c335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIOS System
• Version Model Number: A
• Catalog Number: HELIOS-KW
• Company DUNS: 131480662
• Company Name: TACTICAL MEDICAL SOLUTIONS, 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: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818630010463 [Primary]

FDA Product Code

• IMD: Pack, Hot Or Cold, Disposable

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: 2025-04-03
• Device Publish Date: 2025-03-26

On-Brand Devices [HELIOS System]

• 00818630010463: Casualty hypothermia prevention and management system with active warming for use in pre-hospita
• 00818630010456: Casualty hypothermia prevention and management system for use in pre-hospital environments. Adju