FDA UDI
In Commercial Distribution
🇺🇸 United States
HELIOS System
DI: 00818630010463
·
Model: A
·
TACTICAL MEDICAL SOLUTIONS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HELIOS System
- Primary DI
- 00818630010463
- Version / Model
- A
- Catalog Number
- HELIOS-KW
- Company Name
- TACTICAL MEDICAL SOLUTIONS, LLC
- Labeler DUNS
- 131480662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-26
- Public Version
- 1
- Public Version Date
- 2025-04-03
- Public Version Status
- New
- Public Device Record Key
- 9b130695-188f-494a-a82d-8a8744c8c335
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".
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IMD | Pack, Hot Or Cold, Disposable | Physical Medicine | 890.5710 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818630010463 | GS1 |