FDA.reportPublic FDA data

Medifoam H beauty

Primary DI
08806129660055
Brand
Medifoam H beauty
Company
Genewel Co.,Ltd.
Model
MVmix1
Device description
Medifoam H beauty is intended to manage and assist in wound healing by absorbing exudate in wounds for minimal wound maceration, allowing wound debridement, and creating a moist wound healing environment. This product is provided sterile. After application, this device cannot be reused. A pair of tweezers are included with the product to help pick up the product or packaging, and the tweezers are non-sterile and not a medical device. The Medifoam H beauty does not include a hydrophilic wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.
Published
2022-10-30
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

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806129660147PrimaryGS10
08806129660055Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806129660147088061296601478806129660147
08806129660055088061296600558806129660055

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, chitosan or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
987669599
Device count
3
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806129660185Medifoam12NJ052025-03-03
08806129660208Medifoam bandMBD03401512025-03-03
08806129660222Medifoam H band MediumMB291303M2025-03-03
08806129660239Medifoam H band MediumMB291303M2025-03-03
08806129660253Medifoam H band largeMB352003L2025-03-03
08806129660260Medifoam H band largeMB352003L2025-03-03
08806129660178Medifoam12NJ052025-03-03
08806129660192Medifoam bandMBD03401512025-03-03
08806129660215Medifoam H band MediumMB291303M2025-03-03
08806129660246Medifoam H band largeMB352003L2025-03-03
08806129660109Medifoam HML100100032022-11-30
08806129660000Medifoam HML100100032022-10-30
08806129660031Medifoam12NL022022-10-30
08806129660147Medifoam H beautyMVmix12022-10-30
08806129660161Medifoam H bandMB2513032022-10-30
08806129660048Medifoam HML100100032022-10-30
08806129660093Medifoam12NL022022-10-30
08806129660062Medifoam H bandMB2513032022-10-30

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Primary DI, Brand, Company table
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00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
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