FDA.reportPublic FDA data

Redicare

Primary DI
B70901140081
Brand
Redicare
Company
REDICARE LLC
Model
Burn Gel Dressing 4" x 4"
Catalog number
0114008
Device description
1 Burn Dressing Sterile Gel-Soaked Pad 4"x4"
Published
2020-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
B70901140081PackageHIBCC120In Commercial Distribution
B70901140080PrimaryHIBCC0

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 of polyurethane impregnated with wound gel (e.g., hydrogel) and is applied over the burn to protect against infection, minimize trauma and skin damage, provide pain relief, 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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8665615650info@redicaredirect.com

Regulatory Flags#

DUNS number
800149346
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
B70901140070Redicare"Burn Gel Dressing 4"" x 4"""01140072020-07-28
B70901140080Redicare"Burn 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