FDA.reportPublic FDA data

COOL JAW

Primary DI
00850054025296
Brand
COOL JAW
Company
Medico International Inc
Model
T-850
Catalog number
T-850
Device description
COOL JAW HIGH COMPRESSION WRAP NO CHIN DART, WHITE
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054025296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054025296008500540252968500540252960850054025296

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, reusableA strip or roll of fabric or plastic material intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., treatment of lymphoedema, venous oedema and lipoedema, support injuries associated with minor trauma), and/or to secure hot/cold packs to the body to provide heat/cold therapy. It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-411-7009INFO@COOLJAW.COM

Regulatory Flags#

DUNS number
602828865
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054025005MEDICO INTERNATIONALT-470T-4702023-06-20
00850054025012COOL JAWT-800-1-BLA / T-900CBLAT-900CBLA2023-06-20
00850054025029COOL JAWT-800-1-WH / T-900CT-900C2023-06-20
00850054025036COOL JAWT-800-WH / T-800T-800C2023-06-20
00850054025043CAROMEDT-800C-26-L / 1-8026L1-8026L2023-06-20
00850054025050CAROMEDT-800C-26-M / 1-8026M1-8026M2023-06-20
00850054025067CAROMEDT-800C-26-S / 1-8026S1-8026S2023-06-20
00850054025074CAROMEDT-800C-26-XL / 1-8026XL1-8026XL2023-06-20
00850054025081CAROMEDT-800C-6-L / 1-8006L1-8006L2023-06-20
00850054025098CAROMEDT-800C-6-M / 1-8006M1-8006M2023-06-20
00850054025104CAROMEDT-800C-6-S / 1-8006S1-8006M2023-06-20
00850054025111CAROMEDT-800C-6-XL / 1-8006XL1-8006XL2023-06-20
00850054025128CAROMEDT-800C-6-XS / 1-8006XS1-8006XS2023-06-20
00850054025135CDI MEDICO INTERANTIONALT-800C-B-L / T-124-LT-124-L2023-06-20
00850054025142CDI MEDICO INTERANTIONALT-800C-B-M / T-124-MT-124-M2023-06-20
00850054025159CDI MEDICO INTERANTIONALT-800C-B-S / T-124-ST-124-S2023-06-20
00850054025166CDI MEDICO INTERANTIONALT-800C-BE-L / T-118-LT-118-L2023-06-20
00850054025173CDI MEDICO INTERANTIONALT-800C-BE-M / T-118-MT-118-M2023-06-20
00850054025180CDI MEDICO INTERANTIONALT-800C-BE-S / T-118-ST-118-S2023-06-20
00850054025197CDI MEDICO INTERANTIONALT-800C-HBE-S / T-118HT-118H2023-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917088556WalgreensWALGREEN CO.KGX2026-09-30
08859922800036EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800043EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
00850087488877CeeportCEEPORT INC.KGX2026-09-29
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18