NuMed Industries LLC.

Basic Information

• Brand Name: NuMed Industries LLC.
• Primary DI: 00819123010991
• Version / Model: NM1010SF
• Company Name: Numed Industries, LLC
• Labeler DUNS: 964438910
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2022-09-15
• Public Version: 1
• Public Version Date: 2022-09-23
• Public Version Status: New
• Public Device Record Key: 8b75e1fc-4cdc-4033-8ba9-5c21dacb2b6c

Device Description

NuMed Silver Foam 4x4 is made up of a PU Antibacterial polyurethane foam, polyvinyl alchohal, silver sulfate and silver chloride. It is a highly absorbent foam dressing with 0.35-0.40mg/cm3 ionic silver as the active component. This dressing provides an optimal moist wound healing enviroment, combining an effective antibacterial activity and is indicated for exudate absorption and the management of partial to full thickness wounds, including leg ulcers, pressure ulcers, diabetic foot ulcers, second-degree burns, donor sites, postoperative wounds, and skin abrasions.

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
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
48124	Exudate-absorbent dressing, non-gel, antimicrobial	A wound covering intended to absorb exudates and blood from a wound (e.g., ulcers, burns, surgical wounds, lacerations, abrasions, and/or percutaneous device wounds), and that contains an antimicrobial agent [e.g., silver (Ag), chlorhexidine gluconate (CHG)]. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudate. It is intended to create a moist wound-healing environment and/or protect wounds from external contamination by microorganisms from the periwound skin. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, or powder. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00819123010984	GS1
Primary	00819123010991	GS1

Premarket Submissions

Submission Number	Supplement Number
K140954	000

Device Sizes

Type	Value	Unit	Text
Width	4	Inch
Length	4	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius