FDA.reportPublic FDA data

HAWK Warming Grid

Primary DI
M68959300050
Brand
HAWK Warming Grid
Company
Safeguard US Operating, LLC
Model
05
Catalog number
59-300
Device description
"The HAWK™ Warming Grid is designed to prevent and manage hypothermia. 1 ea 23"" x 20"" HAWK Warming Grid with absorbent pad"
Published
2024-11-15
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMDPack, Hot Or Cold, DisposablePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M68959300050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, single-useA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel, peat) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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M689GOIO040GO IO Intraosseous Start Kit 12/Case04GO IO2024-12-12
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M6898010020040INTRAVENOUS INFUSION STARTER SET Case of 200480-100-202026-05-04
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M68980801R120Fresh Whole Blood Recipient Set1280-801-R2026-05-04
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M689801101006080-110-10 Saline Lock Kit Case of 100680-110-102026-05-29
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M6898143003020Maritime Boat Box - Advanced0281-430-032026-05-28
M6898444601190Mojo Multi Mission - Advanced1984-446-012026-05-27
M689HHCTUINK01050Chest Tube Insertion Kit05HHCTUINK012026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 505HHCTUINK01-052026-05-27
M689801101005080-110-10 Saline Lock Kit Case of 100580-110-102025-04-16
M68980110140SALINE LOCK KIT1480-1102025-01-11
M6898143003010Maritime Boat Box - Advanced0181-430-032025-07-11
M689HHCTUINK01040Chest Tube Insertion Kit04HHCTUINK012025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
08436587170522ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-18
08436587170010ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170027ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170065ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170102ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170249ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170362ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170386ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170553ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170560ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170577ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170638ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170812ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170843ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170942ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170966ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170973ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171017ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171031ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171208ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171253ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171284ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171314ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171338ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171352ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15