DEVICE: NPseal 25 (10860004811395)
Device Identifier (DI) Information
NPseal 25
GM01-005
In Commercial Distribution
Guard Medical Inc.
GM01-005
In Commercial Distribution
Guard Medical Inc.
NPseal 25 Advanced Negative Pressure Dressing (box of 10, Large)
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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 |
---|---|
OKO | Negative Pressure Wound Therapy Non-Powered Suction Apparatus |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K241522 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: less than 23 Degrees Celsius |
Special Storage Condition, Specify: Keep out of direct sunlight |
Special Storage Condition, Specify: Keep away from moisture during storage |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
ae086175-3daa-4613-ab73-ac81a4f0cc9c
October 30, 2024
1
October 22, 2024
October 30, 2024
1
October 22, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00860004811398
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8884173644
info@guard-medical.com
info@guard-medical.com