FDA.reportPublic FDA data

Luxamend

Primary DI
10369489522067
Brand
Luxamend
Company
Journey Medical Corporation
Model
1
Published
2023-02-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122595000HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAMDermal Life, LLC2013-05-01FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00369489522060PrimaryGS10
10369489522067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00369489522060003694895220603694895220600369489522060
1036948952206710369489522067

GMDN Terms#

Term, Definition table
TermDefinition
Dry skin moisture barrier dressingA substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079640860
Device count
10
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00369489522060Luxamend12023-02-10
00369489522145Luxamend12023-02-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00050428280669CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
00050428453599CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFRO2026-06-04
50192253067901ASOCardinal Health 200, LLCFRO2026-06-03
00714196111050DermaRite Medical DermaHoney Medical Grade Honey 0.5 oz TubeSion Brands LLCFRO2026-06-01
00714196111074DermaRite Medical DermaHoney Medical Grade Honey 1.75 oz TubeSion Brands LLCFRO2026-06-01
01714196222045DermaRite Medical DermaHoney Tulle Non Border Honey Gauze 4x4Sion Brands LLCFRO2026-06-01
01714196333048DermaRite Medical DermaHoney Border Medical Grade Honey Sheet 4x4Sion Brands LLCFRO2026-06-01
08717249680130DermaRite Medical L-Mesitran 0.5 oz TubeSion Brands LLCFRO2026-06-01
08717249680147DermaRite Medical L-Mesitran 1.75 oz TubeSion Brands LLCFRO2026-06-01
00850087488259CeeportCEEPORT INC.FRO2026-05-29
00850087488266CeeportCEEPORT INC.FRO2026-05-29
10080196415397MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415386MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277415393MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677289MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
10888277677296MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-27
00850087488006CeeportCEEPORT INC.FRO2026-05-22
10197344175994MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-05-20
10840330706688ProCureTwin Med, LLCFRO2026-05-04
00324357020451Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357020680Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
00324357060440Zeni MedicalFocus Health Group, Inc.FRO2026-04-13
09551012610035ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610196ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610363ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
09551012610370ELECTROCYN somaV3BIO SDN. BHD.FRO2026-04-02
10192253046403KendallCardinal Health 200, LLCFRO2026-03-25
10192253046519KendallCardinal Health 200, LLCFRO2026-03-25
09120073781536GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10
09120073781543GranudacynP.G.F. Industry Solutions GmbHFRO2026-02-10