FDA.reportPublic FDA data

Negative Pressure Wound Therapy System Foam Dressing

Primary DI
B530UDP130
Brand
Negative Pressure Wound Therapy System Foam Dressing
Company
LC MEDICAL CONCEPTS
Model
UPD13
Catalog number
UDP13
Device description
NPWT Suction Dome Pad connection tube and ported pad
Published
2019-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
B530UDP131PackageHIBCC10In Commercial Distribution
B530UDP130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system foam dressing, non-antimicrobialA 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 does not include an antimicrobial agent(s). 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
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B530LCW151010Dressing, Wound, HydrophilicLCW151012020-01-23
B530UN25163L0Negative Pressure Wound Therapy System Foam DressingUN25163L2019-02-11
B530UTD250Negative Pressure Wound Therapy System Foam DressingUTD24UTD242020-01-23
B530UN1083S0Negative Pressure Wound Therapy System Foam DressingUN1083SUN1083S2019-02-05
B530UN20133M0Negative Pressure Wound Therapy System Foam DressingUN20133M2019-02-11
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

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