DEVICE: HELIOS System (00818630010456)
Device Identifier (DI) Information
HELIOS System
A
In Commercial Distribution
HELIOS-K
TACTICAL MEDICAL SOLUTIONS, LLC
A
In Commercial Distribution
HELIOS-K
TACTICAL MEDICAL SOLUTIONS, LLC
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".
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62340 | Hypothermia-prevention whole-body suit |
A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IMD | Pack, Hot Or Cold, Disposable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ee4f0d52-f634-4e4c-b146-4c4dee00987d
April 03, 2025
1
March 26, 2025
April 03, 2025
1
March 26, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined