FDA.reportPublic FDA data

Redicare

Primary DI
B70901070040
Brand
Redicare
Company
REDICARE LLC
Model
"Instant Ice Pack 5"" x 8"""
Catalog number
0107004
Device description
"1 Instant Ice Pack Compress Large 5"" x 8"" "
Published
2020-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
B70901070041PackageHIBCC40In Commercial Distribution
B70901070040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, single-useA non-powered 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) 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, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Width5Inch

Contacts#

Phone, Email table
PhoneEmail
8665615650info@redicaredirect.com

Regulatory Flags#

DUNS number
800149346
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B70901070010Redicare"Instant Ice Pack 4"" x 5"""01070012020-07-28
B70901040251Redicare"Sterile Pads 3"" x 3"""01040252020-07-28
B70901040341Redicare"Non Adherent Pad 2"" x 3"""01040342020-07-28
B70901020180RedicareResuscitation Kit01020182020-07-28
B70901020760RedicareResuscitation Kit01020762020-07-28
B70901130700RedicareArterial Tourniquet with Windlass01130702022-04-28
B70903030130RedigloveNitrile Examination Glove03030132022-04-28
B70903030131RedigloveNitrile Examination Glove03030132022-04-28
B70901140070Redicare"Burn Gel Dressing 4"" x 4"""01140072020-07-28
B70901140080Redicare"Burn Gel Dressing 4"" x 4"""01140082020-08-25
B70901140081RedicareBurn Gel Dressing 4" x 4"01140082020-08-25
B70901030021RedicarePlastic Bandages Wide Strips01030022020-07-28
B70901030041RedicareFabric Wide Strip Bandage01030042020-07-28
B70901030071RedicareFabric Knuckle Bandage01030072020-07-28
B70901030131RedicareFingertip XL Fabric Bandage01030132020-07-28
B70901030161RedicareLarge Patch Fabric Bandages01030162020-07-28
B70901030171RedicareSuper Large Patch Fabric Bandages01030172020-07-28
B70901030221RedicareJunior Strip Fabric Bandages01030222020-07-28
B70901040100RedicareCohesive Flex Bandage01040102020-07-28
B70901040411Redicare"Combine Trauma Dressing 5"" x 9"""01040412020-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08436587171505ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15
08436587171666ANF Therapy®AMINO FREQUENCY CORPORATION SL.IMD2026-05-15