FDA.reportPublic FDA data

NAR

Primary DI
00842209110971
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
80-0027
Device description
Hypothermia Prevention and Management Kit (HPMK)
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
00842209110971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209110971008422091109718422091109710842209110971

GMDN Terms#

Term, Definition table
TermDefinition
Activated-medium surgical warming blanketA non-sterile device intended to help prevent a patient from cooling prior to, during, and after a surgical intervention by serving as a heat-generating cover. It is a highly hygienic device made of plastic material and designed with integrated pockets that hold air-activated warming pads containing various media [e.g., active coal, clay, or salt and iron (Fe) powder] that chemically generate heat when the device is removed from its sealed packaging. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832426782
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842209128198NAR83-003583-00352023-08-10
00842209105083NAR Kit83-001483-00142018-09-14
00842209105090NAR83-001583-00152018-09-14
00842209105342NAR Kit83-000783-00072018-09-14
00842209105373NAR Kit83-002083-00202018-09-14
00842209139620NAR84-0004A84-0004A2026-08-19
00842209139637NAR84-0007A84-0007A2026-08-19
00842209139644NAR84-0020A84-0020A2026-08-19
00842209139651NAR84-0023A84-0023A2026-08-19
00842209139668NAR84-0135A84-0135A2026-08-19
00842209139675NAR84-0138A84-0138A2026-08-19
00842209139682NAR80-1483A80-1483A2026-08-19
00842209139699NAR80-198580-19852026-08-19
00842209139705NAR84-020584-02052026-08-19
00842209139712NAR77-015377-01532026-08-19
00842209139729NAR82-0049P82-0049P2026-08-19
00842209139736NAR82-0051P82-0051P2026-08-19
00842209139743NAR82-0075P82-0075P2026-08-19
00842209139750NAR82-0077P82-0077P2026-08-19
00842209139767NAR80-1166P80-1166P2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538937HalyardMEDICAL ACTION INDUSTRIES INC.KME2026-09-24
00860015694799Prism Microclimate PadPrism Pacific Industries LLCKME2026-08-27
04260647540321TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
04260647540345TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
04260647540369TECOtherm Wrabbit +transTec Com Medizintechnik GmbHKME2026-08-26
00199972000535CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000559CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00199972000573CuraplexBOUND TREE MEDICAL, LLCKME2026-08-15
00845819082003Oasis REST & RELIEF Single-UseOASIS MEDICAL, INC.IMD2026-08-14
00845819083000Oasis REST & RELIEF Plus Single-UseOASIS MEDICAL, INC.IMD2026-08-14
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 228Dynarex CorporationKME2026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"Dynarex CorporationKME2026-07-31
10080196158652MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.IMD2026-07-16
00808829131321Lucky Super SoftDELTA BRANDS INC.IMD2026-07-10
00840456201435JMUJMU DENTAL, INCKME2026-07-06
00840456206362JMUJMU DENTAL, INCKME2026-07-06
00049696561518B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00049696562102B.PUREFOURSTAR GROUP INC.IMD2026-06-09
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)Dynarex CorporationKME2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)Dynarex CorporationKME2026-06-08
16931918119823AllesetGRI Medical & Electronic Technology Co., Ltd.KME2026-06-04
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