DEVICE: Negative Pressure Wound Therapy System Foam Dressing (B530UN25163L0)
Device Identifier (DI) Information
Negative Pressure Wound Therapy System Foam Dressing
UN25163L
In Commercial Distribution
LC MEDICAL CONCEPTS
UN25163L
In Commercial Distribution
LC MEDICAL CONCEPTS
Large Black Foam Negative Pressure Wound Therapy Dressing Kit
Device Characteristics
MR Unsafe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47406 | Negative-pressure wound therapy system foam dressing, non-antimicrobial |
A 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OMP | Negative Pressure Wound Therapy Powered Suction Pump |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8d94cfdc-77ef-4a20-8947-a9c831fa4df8
June 19, 2020
2
February 11, 2019
June 19, 2020
2
February 11, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B530UN25163L1 | 20 | B530UN25163L0 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined