FDA.reportPublic FDA data

Hypothermia Management Set

Primary DI
M68959120000
Brand
Hypothermia Management Set
Company
Safeguard US Operating, LLC
Model
00
Catalog number
59-120
Device description
"HYPOTHERMIA MANAGEMENT SET1 ea - 7.5"" x 6.5"" Blizzard Light Blanket, 1 ea - 34"" x 48"" Ready-Heat warming blanketWARNING: Do not place Ready-Heat on exposed skin."
Published
2018-04-04
Public version status
Update
Distribution status
Not 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
M68959120000PrimaryHIBCC0

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
118492643
Device count
1
Premarket exempt
true
Kit
true

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