HELIOS System

Primary DI
00818630010456
Brand
HELIOS System
Company
TACTICAL MEDICAL SOLUTIONS, LLC
Model
A
Catalog number
HELIOS-K
Device description
"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"". "
Published
2025-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IMDPack, Hot Or Cold, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818630010456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818630010456008186300104568186300104560818630010456

GMDN Terms#

Term, Definition table
TermDefinition
Hypothermia-prevention whole-body suitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131480662
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818630019053BRIDGE™ FRIDGE RefrigeratorA1041262026-05-05
00818630019008Expeditionary Refrigerator (xFRIDGE™)A1039872026-04-24
00860015036803Expeditionary RefrigeratorA2026-01-07
00199284492608TacMed™ Vascular Access KitAVAK2025-04-29
00818630016328Tension Pneumothorax Kit w/ CapnospotA2025-03-31
00818630010463HELIOS SystemAHELIOS-KW2025-03-26
00818630010524Foxtrot Litter with ACU CarrierAF-LITC-A2020-10-21
00818630010531Foxtrot Litter with Black CarrierAF-LITC-B2020-10-21
00818630010555Foxtrot Litter with Tan CarrierAF-LITC-T2020-10-21
00818630010562Foxtrot Litter DA, with ACU CarrierAF-LITC-DA-A2020-10-21
00818630010579Foxtrot Litter DA, with Black CarrierAF-LITC-DA-B2020-10-21
00818630010586Foxtrot Litter DA, with Tan CarrierAF-LITC-DA-T2020-10-21
00818630014027Foxtrot Litter DA, with Orange CarrierAF-LITC-DA-RO2020-10-21
00818630014508Foxtrot Litter with Orange CarrierAF-LITC-RO2020-10-21
00818630014515Foxtrot Litter with Red CarrierAF-LITC-R2020-10-21
00818630014522Foxtrot Litter DA, with Red CarrierAF-LITC-DA-R2020-10-21
00818630014539Foxtrot Litter DA, with Green CarrierAF-LITC-DA-OD2020-10-21
00818630014546Foxtrot Litter, No CarrierAF-LIT2020-10-21
00818630014553Foxtrot Litter DA, no CarrierAF-LIT-DA2020-10-21
00818630014584Foxtrot Litter with Green CarrierAF-LITC-OD2020-10-21

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