FDA.reportPublic FDA data

LUOFUCON

Primary DI
86940610104456
Brand
LUOFUCON
Company
Huizhou Foryou Medical Devices Co., Ltd.
Model
100×100 mm
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

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
K242856000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242856000LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)Huizhou Foryou Medical Devices Co., Ltd.2024-11-13FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
86940610104456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
8694061010445686940610104456

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for wound trauma, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Regulatory Flags#

DUNS number
529904325
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06940610127725Vliwasorb105×105(50×50)mm1595582026-08-14
06940610127787Vliwasorb180×180(125×125)mm1595602026-08-14
06940610127848Vliwasorb250×200(190×140)mm1595622026-08-14
06940610127879Vliwasorb185×180(125×120)mm1595682026-08-14
06940610127909Vliwasorb230×230(170×165)mm1595692026-08-14
06940610127930Vliwasorb220×220(160×155)mm1595702026-08-14
86940610104432LUOFUCON100×100 mm2026-03-25
86940610104449LUOFUCON100×100 mm2026-03-25
86940610104463LUOFUCON100ml2026-03-25
06940610104726Vliwasorb75×75 (50×50)mm1418202025-11-18
06940610104733Vliwasorb125×125 (100×100)mm1418212025-11-18
06940610104740Vliwasorb100×200 (75×170)mm1418222025-11-18
06940610104757Vliwasorb150×250 (120×220)mm1418232025-11-18
06940610104764Vliwasorb200×200(170×170)mm1418242025-11-18
06940610104771Vliwasorb200×300(170×270)mm1418252025-11-18
06940610127756Vliwasorb130×130(75×75)mm1595592025-11-18
06940610127817Vliwasorb250×150 (190×90)mm1595612025-11-18
06940610104788Vliwasorb75×75 (50×50)mm1418202025-11-18
06940610104795Vliwasorb125×125 (100×100)mm1418212025-11-18
06940610104801Vliwasorb100×200 (75×170)mm1418222025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014518331PurForm AMKAIROS BIOSCIENCES LLCFRO2026-10-07
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00886333217595V+PadARGON MEDICAL DEVICES, INC.FRO2026-10-07
00612553000163VERISHARTMANN USA, INC.FRO2026-10-01
00612553000170VERISHARTMANN USA, INC.FRO2026-10-01
00612553000187VERISHARTMANN USA, INC.FRO2026-10-01
00612553000194VERISHARTMANN USA, INC.FRO2026-10-01
00194346726707equateWAL-MART STORES, INC.FRO2026-09-30
00194346726714equateWAL-MART STORES, INC.FRO2026-09-30
10885380214714CurityCardinal Health 200, LLCFRO2026-09-30
10885380214738CurityCardinal Health 200, LLCFRO2026-09-30
00810226440944ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440951ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226440968ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442542ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442559ViveCareVIVE HEALTH LLCFRO2026-09-29
00810226442566ViveCareVIVE HEALTH LLCFRO2026-09-29
00810178885329Vive CareVIVE HEALTH LLCFRO2026-09-28
10885380214707CurityCardinal Health 200, LLCFRO2026-09-28
10885380214721CurityCardinal Health 200, LLCFRO2026-09-28
10885380214745CurityCardinal Health 200, LLCFRO2026-09-28
10885380214752CurityCardinal Health 200, LLCFRO2026-09-28
10885380214769CurityCardinal Health 200, LLCFRO2026-09-28
10885380214776CurityCardinal Health 200, LLCFRO2026-09-28
10885380214783CurityCardinal Health 200, LLCFRO2026-09-28
10885380214790CurityCardinal Health 200, LLCFRO2026-09-28
10885380214806CurityCardinal Health 200, LLCFRO2026-09-28
10888277415010MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
10888277415027MEDLINEMEDLINE INDUSTRIES, INC.FRO2026-09-04
00841277111187Novera RenewHarps USA, Inc.FRO2026-08-26