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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M68931200070CrOC0731-2002026-10-08
M6898723101011Bleeding Control Kit0187-231-012022-09-15
M689SHSTARTPAXSM010SCHOOL TRAUMA ADVANCED RESPONSE KIT01SH-START-PAX-SM2022-09-26
M68981129060Mojo Patrol IFAK II0681-1292026-08-26
M689SDREDC1OTC050SDR-EDC1-OTC05SDR-EDC1-OTC2026-08-26
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M68981139010LEO Patrol Kit0181-1392026-08-25
M68981301030MARCH IFAK Refill0381-3012026-08-25
M6898130330010MARCH IFAK RESUPPLY Cs of 300181-303-302026-08-25
M68981605020K9 Trauma Kit0281-6052026-08-25
M68987155030TX Bleeding Control Kit - Advanced0387-1552026-08-25
M68987232010Stop the Bleed Kit (NJSP)0187-2322026-08-25
M689SDREDC1OTC010SDR-EDC1OTC01SDR-EDC1OTC2026-08-25

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00845819082003Oasis REST & RELIEF Single-UseOASIS MEDICAL, INC.IMD2026-08-14
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10080196158652MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.IMD2026-07-16
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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
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08436587170225ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587170232ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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08436587170867ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
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