FDA.reportPublic FDA data

Redicare

Primary DI
B70901140070
Brand
Redicare
Company
REDICARE LLC
Model
"Burn Gel Dressing 4"" x 4"""
Catalog number
0114007
Device description
"1 Burn Gel Dressing 4""x4"""
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

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B70901140071PackageHIBCC160In Commercial Distribution
B70901140070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic polymer burn dressing, gel-coatedA sterile covering designed to treat small to large patient burns. It is made from synthetic polymer material impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is available in various sizes (e.g., 10x10 cm to 60x40 cm) and may be body contoured; it is also available in prefabricated shapes (e.g., face mask). It is typically used by emergency medical services (EMS) and critical care units, but may also be used in the home. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Centimeter
Width10Centimeter

Regulatory Flags#

DUNS number
800149346
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B70901070010Redicare"Instant Ice Pack 4"" x 5"""01070012020-07-28
B70901070040Redicare"Instant Ice Pack 5"" x 8"""01070042020-07-28
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
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
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
06974600043672KONLIDASuzhou Konlida Medical Supplies Co., Ltd.NAE2025-07-28
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
06971292003694AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
06971292003700AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14