FDA.reportPublic FDA data

NuMed Industries LLC.

Primary DI
00819123011028
Brand
NuMed Industries LLC.
Company
Numed Industries, LLC
Model
NM5050SBF
Device description
NuMed Silver Bordered Foam 2x2 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.
Published
2022-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140954000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140954000LUOFUCON SILVER PU ANTIBACTERIAL FOAM DRESSINGHuizhou Foryou Medical Devices Co., Ltd.2015-03-23FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819123011028PrimaryGS10
00819123011011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819123011028008191230110288191230110280819123011028
00819123011011008191230110118191230110110819123011011

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, non-gel, antimicrobialA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Inch
Width2Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
964438910
Device count
200
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819123010571NuMed Industries LLC. NM5050COL2023-02-04
00819123010960NuMed Industries LLC. NM5050SF2022-09-15
00819123010991NuMed Industries LLC. NM1010SF2022-09-15
00819123011059NuMed Industries LLC. NM1010SBF2022-09-15
10819123010684NuMed Industries LLC. B-NM1012SAD2022-09-14
10819123010691NuMed Industries LLC. B-NM3530SAD2022-09-14
20819123010544NuMed Industries LLC. NM1012SAD2022-09-14
20819123010568NuMed Industries LLC. NM3530SAD2022-09-14
00819123010687NuMed Industries LLC. B-NM1012SAD2022-09-14
00819123010694NuMed Industries LLC. B-NM3530SAD2022-09-14
10819123010547NuMed Industries LLC. NM1012SAD2022-09-14
10819123010561NuMed Industries LLC. NM3530SAD2022-09-14
20819123010537NuMed Industries LLC. NM5050SAD2022-09-13
10819123010530NuMed Industries LLC. NM5050SAD2022-09-13
10819123010677NuMed Industries LLC. B-NM5050SAD2022-08-01
00819123010670NuMed Industries LLC. B-NM5050SAD2022-08-01

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Primary DI, Brand, Company table
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05059884011195Suprasorb Liquacel AgSPECIALITY FIBRES AND MATERIALS LIMITEDFRO2026-10-15
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00841277111378Novera SeamHarps USA, Inc.FRO2026-10-14
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00841277111392Novera SeamHarps USA, Inc.FRO2026-10-14
00841277111408Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111382Novera SeamHarps USA, Inc.FRO2026-10-14
10841277111405Novera SeamHarps USA, Inc.FRO2026-10-14
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10885380214813DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214820DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214837DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214844DermaceaCardinal Health 200, LLCFRO2026-10-09
10885380214851DermaceaCardinal Health 200, LLCFRO2026-10-09
06977727072259Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.FRO2026-10-08
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