HELIOS System

Primary DI
00818630010463
Brand
HELIOS System
Company
TACTICAL MEDICAL SOLUTIONS, LLC
Model
A
Catalog number
HELIOS-KW
Device description
"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""."
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
00818630010463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818630010463008186300104638186300104630818630010463

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
Expiration date on label
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
00818630010456HELIOS SystemAHELIOS-K2025-03-26
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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