DEVICE: Areza Medical (00850021481902)
Device Identifier (DI) Information
Areza Medical
F5410
In Commercial Distribution
F5410
ADVANCED MEDICAL ASSOCIATES, LLC
F5410
In Commercial Distribution
F5410
ADVANCED MEDICAL ASSOCIATES, LLC
Areza Foam Dressing is a sterile, disposable, soft, and highly absorbent foam dressing composed of polyurethane (PU) with a waterproof PU film backing, which may act as a physical barrier to infectious contaminants. Its design consists of small, open cells with a high absorptive capability making this dressing ideal for excessive exuding wounds. The dressing maintains a moist environment, ideal for wound healing, while also decreasing maceration to the surrounding, peri-wound, skin. The area in contact with the wound surface is non-adhesive for easy removal as long as the foam is moist. The part of the dressing that faces the wound has a small risk of adhering to wound surface if the wound is bleeding and/or has a low exudate. It is ideal to be used in partial and full-thickness wounds.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
46854 | Wound-nonadherent dressing, absorbent, non-antimicrobial |
A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAD | Dressing, Wound, Occlusive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in a cool, dry place. Avoid excessive heat |
Clinically Relevant Size
[?]Size Type Text |
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Length: 5 Inch |
Width: 4 Inch |
Device Record Status
fb2e4d64-a10d-4a57-ad4c-fce19cbcee97
November 04, 2024
1
October 26, 2024
November 04, 2024
1
October 26, 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 |
---|---|---|---|---|---|
00850021481926 | 16 | 00850021481902 | In Commercial Distribution | Inner case | |
00850021481933 | 32 | 00850021481902 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00850021481322
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
(214) 356-8716
info@arezamedical.com
info@arezamedical.com