FDA.reportPublic FDA data

HAWK Advanced Hypothermia Management Set

Primary DI
M68959320040
Brand
HAWK Advanced Hypothermia Management Set
Company
Safeguard US Operating, LLC
Model
04
Catalog number
59-320
Device description
HAWK Advanced Hypothermia Management Set is designed to help prevent and manage hypothermia.
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
M68959320040PrimaryHIBCC0

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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M68980801R110Fresh Whole Blood Recipient Set1180-801-R2025-03-04
M68980100140INTRAVENOUS INFUSION STARTER SET 1480-1002024-12-27
M6898010020030INTRAVENOUS INFUSION STARTER SET Case of 200380-100-202024-12-27
M68980801R100Fresh Whole Blood Recipient Set1080-801-R2024-12-16
M68980801050Fresh Whole Blood Transfusion Set580-8012022-08-09
M6898141003030Maritime First Aid Resupply - Advanced0381-410-032026-04-07

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