FDA.reportPublic FDA data

Hypothermia Management Set

Primary DI
M68959120030
Brand
Hypothermia Management Set
Company
Safeguard US Operating, LLC
Model
03
Catalog number
59-120
Device description
Blizzard products are compact, lightweight, and an integral part of any emergency kit and quickly warm the patient and allow rescuers to more effectively manage hypothermia. These products are ideally suited for the casual outdoor enthusiast, as an emergency aid in the car or any situation requiring hypothermia management.
Published
2025-10-24
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
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68959120030PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Kit
true

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