DEVICE: NPseal 25 (10860004811395)

Device Identifier (DI) Information

NPseal 25
GM01-005
In Commercial Distribution

Guard Medical Inc.
10860004811395
GS1

10
118095992 *Terms of Use
NPseal 25 Advanced Negative Pressure Dressing (box of 10, Large)
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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
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FDA Product Code

[?]
Product Code Product Code Name
OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K241522 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ae086175-3daa-4613-ab73-ac81a4f0cc9c
October 30, 2024
1
October 22, 2024
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00860004811398 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8884173644
info@guard-medical.com
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