NuMed Industries LLC.

Primary DI
00819123010670
Brand
NuMed Industries LLC.
Company
Numed Industries, LLC
Model
B-NM5050SAD
Device description
NuMed Silver Alginate 2x2 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.
Published
2022-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K120181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120181000LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MMHuizhou Foryou Medical Devices Co., Ltd.2013-02-14FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10819123010677PrimaryGS10
00819123010670Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081912301067710819123010677
00819123010670008191230106708191230106700819123010670

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964438910
Device count
500
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00819123011028NuMed Industries LLC. NM5050SBF2022-09-15
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

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