Foam Medium

Basic Information

• Brand Name: Foam Medium
• Primary DI: 00849405031222
• Version / Model: XF-MFOAM2
• Company Name: GENADYNE BIOTECHNOLOGIES INC.
• Labeler DUNS: 006616130
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-27
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 8a334ecf-fcb1-414f-9bfe-373f9ac1de30

Device Description

Genadyne Green Foam Dressing is a fully reticulated hydrophobic polyurethane foam made with polyether resin to allow better hydrolytic stability. While under pressure, this design allows increased performance in moist environments. The Foam promotes perfusion and assist in tissue granulation. In addition, fraying is reduced, preventing stray pieces from being left in the wound bed. It is a non-invasive, non-implantable medical device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47406	Negative-pressure wound therapy system foam dressing, non-antimicrobial	A pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure, commonly known as negative pressure wound therapy (NPWT); it does not include an antimicrobial agent(s). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849405031222	GS1

Premarket Submissions

Submission Number	Supplement Number
K092992	000

Device Sizes

Type	Value	Unit	Text
Depth	3.3	Centimeter
Length	12.5	Centimeter
Width	18	Centimeter