HELIOS System HELIOS-K

GUDID 00818630010456

Casualty hypothermia prevention and management system for use in pre-hospital environments. Adjustable two-piece blanket casualty wrap system design for quick access to the casualty. 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: 00818630010456
• NIH Device Record Key: ee4f0d52-f634-4e4c-b146-4c4dee00987d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELIOS System
• Version Model Number: A
• Catalog Number: HELIOS-K
• 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: false
• 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	00818630010456 [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