FDA.reportPublic FDA data

HAWK w/Carrier Set

Primary DI
M6898331501010
Brand
HAWK w/Carrier Set
Company
Safeguard US Operating, LLC
Model
01
Catalog number
83-315-01
Device description
"HAWK Advanced Hypothermia Management Set with Carrier Set1 ea - 23"" x 20"" HAWK Waring Grid with absorbent pad, 1 ea - 32"" x 81"" Thermal Patient Litter SystemWarning: Not for use on infants. Do not separate the HAWK Warming Grid from the absorbent pad. Device has the potential to produce burns. Always monitor and reassess during use."
Published
2018-07-30
Public version status
Update
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
M6898331501010PrimaryHIBCC0

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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