Medifoam H beauty

GUDID 08806129660055

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.

Genewel Co.,Ltd.

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

• Primary Device ID: 08806129660055
• NIH Device Record Key: 3c67a59f-2b4e-4db0-b37a-fd8cf17ab127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medifoam H beauty
• Version Model Number: MVmix1
• Company DUNS: 987669599
• Company Name: Genewel Co.,Ltd.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806129660055 [Unit of Use]
GS1	08806129660147 [Primary]

FDA Product Code

• NAC: Dressing, Wound, Hydrophilic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-30

Devices Manufactured by Genewel Co.,Ltd.

• 08806129660048 - Medifoam H: 2022-11-07
• 08806129660093 - Medifoam: 2022-11-07 Medifoam is indicated for the management of exuding wounds such as ulcers, burns, surgical/traumatic/acute, lacerations, abrasio
• 08806129660055 - Medifoam H beauty: 2022-11-07Medifoam 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.
• 08806129660055 - Medifoam H beauty: 2022-11-07 Medifoam H beauty is intended to manage and assist in wound healing by absorbing exudate in wounds for minimal wound maceration,
• 08806129660062 - Medifoam H band: 2022-11-07