NuMed Industries LLC.

GUDID 10819123010561

NuMed Silver Alginate Rope Dressing, conformable wound dressings with a high mannuronic acid content. The silver impregnated alginate fibers, 1.4% w/w silver as silver calcium alginate per dressing, forms a gel when in contact with wound exudate or blood, which creates a moist wound healing environment. The silver in the alginate wound dressing has an antibacterial effect on various types of bacteria including; Staphylococcus aureus and E coli. The sustained release of silver ions protects the dressing from a broad spectrum of bacterial contamination over a period of up to 3 days.

Numed Industries, LLC

Exudate-absorbent dressing, non-gel, antimicrobial

• Primary Device ID: 10819123010561
• NIH Device Record Key: 0239da04-101f-4c0d-a08a-558e8b60f594
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuMed Industries LLC.
• Version Model Number: NM3530SAD
• Company DUNS: 964438910
• Company Name: Numed Industries, LLC
• Device Count: 400
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch
• Width: 0.35 Inch
• Length: 12 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10819123010561 [Unit of Use]
GS1	20819123010568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120181

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2022-09-22
• Device Publish Date: 2022-09-14

On-Brand Devices [NuMed Industries LLC. ]

• 00819123010670: NuMed Silver Alginate 2x2 Dressing, conformable wound dressings with a high mannuronic acid cont
• 10819123010530: NuMed Silver Alginate 2x2 Dressing, conformable wound dressings with a high mannuronic acid cont
• 10819123010561: NuMed Silver Alginate Rope Dressing, conformable wound dressings with a high mannuronic acid con
• 10819123010547: NuMed Silver Alginate 4x5 Dressing, conformable wound dressings with a high mannuronic acid cont
• 00819123010694: NuMed Silver Alginate Rope Dressing, conformable wound dressings with a high mannuronic acid con
• 00819123010687: NuMed Silver Alginate 4x5 Dressing, conformable wound dressings with a high mannuronic acid cont
• 00819123010571: Type I Collagen is the most abundant type of collagen in the human body. As the main component o