FDA.reportPublic FDA data

Negative Pressure Wound Therapy System Foam Dressing

Primary DI
B530UN20133M0
Brand
Negative Pressure Wound Therapy System Foam Dressing
Company
LC MEDICAL CONCEPTS
Model
UN20133M
Device description
Medium Black Foam Negative Pressure Wound Therapy Dressing Kit
Published
2019-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B530UN20133M1PackageHIBCC20In Commercial Distribution
B530UN20133M0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressingA pad made of open-cell foam material designed to be placed into a wound during a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically used to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. Under NPWT, the open-cell foam dressing decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure. It may be cut to conform to the wound. This is a single-use device.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
093992526
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B530LCW151011Dressing, Wound, HydrophilicLCW151012020-01-23
B530UTD241Negative Pressure Wound Therapy System Foam DressingUTD24UTD242020-01-23
B530UDP131Negative Pressure Wound Therapy System Foam DressingUPD13UDP132019-02-11
B530UN25163L1Negative Pressure Wound Therapy System Foam DressiUN25163L2019-02-11
B530UN1083S0Negative Pressure Wound Therapy System Foam DressiUN1083SUN1083S2019-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10849405002793Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002809Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002816Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002823Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002830Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
10849405002847Hybrid Dressing - Revo UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-16
00849405002581Genadyne DUO NPWTGENADYNE BIOTECHNOLOGIES INC.OMP2026-03-09
00849405024101XLR8 Abdominal Wound Dressing Kit GENADYNE BIOTECHNOLOGIES INC.OMP2026-03-09
14897089070085ExtriCAREALLEVA MEDICAL LIMITEDOMP2026-03-05
14897089070108ExtriCAREALLEVA MEDICAL LIMITEDOMP2026-03-05
04897089070330ExtricareALLEVA MEDICAL LIMITEDOMP2026-03-02
04897089070446ExtricareALLEVA MEDICAL LIMITEDOMP2026-03-02
14897089070689ExtriCAREALLEVA MEDICAL LIMITEDOMP2026-03-02
50749756392490DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002598Hybrid DressingGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
00849405002659XLR8/XLR8+ Port - UnsterileGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
00849405002666XLR8 Transparent Film DressingGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
14897089070160ExtriCARE ALLEVA MEDICAL LIMITEDOMP2025-12-03
14897089070207ExtricareALLEVA MEDICAL LIMITEDOMP2025-12-03
10849405002595Hybrid DressingGENADYNE BIOTECHNOLOGIES INC.OMP2025-12-03
00851978007801Ultra Seal Preferred Strips (5/pouch)Pensar Medical, LLCOMP2025-12-01
00840117345539Durma+ Y-Type Suction Drainage Tube, 10 Fr Dynarex CorporationOMP2025-11-24
00840117345553Duma+ Straight Suction Drainage Tube, 10 FrDynarex CorporationOMP2025-11-24
00850590008203PWD™ Platform Wound Dressing Negative Pressure SysteAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
00850590008210PWD™ Platform Wound Dressing Negative Pressure SysteMAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
00850590008234PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
00850590008258PWD™ Platform Wound Dressing Negative Pressure SystemAPPLIED TISSUE TECHNOLOGIES LLCOMP2025-11-20
05000223499389RENASYSSMITH & NEPHEW MEDICAL LIMITEDOMP2025-09-23
05000223499396RENASYSSMITH & NEPHEW MEDICAL LIMITEDOMP2025-09-23
05000223499402RENASYSSMITH & NEPHEW MEDICAL LIMITEDOMP2025-09-23