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NuMed Industries LLC.

FDA UDI

Class U (US FDA UDI)

by Numed Industries, LLC

Identity

Trade Name
NuMed Industries LLC. FDA UDI
Generic Name
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
Device Name
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. FDA UDI
Model / Reference
NM1010SF FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
00819123010991 FDA UDI
510(k) Number
K140954 FDA UDI
FDA Product Code
FRO FDA UDI
GMDN Term
Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 4 Inch FDA UDI
Length — 4 Inch FDA UDI

Category: Exudate-absorbent dressing, non-gel, antimicrobial

NuMed Industries LLC. by Numed Industries, LLC — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.

Cleared under the same submission

K140954 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Numed Industries, LLC

Sources (1)

  • FDA UDI 8b75e1fc-4cdc-4033-8ba9-5c21dacb2b6c 36 fields · synced Jun 1, 2026