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Areza Medical

FDA UDI

Class I (US FDA UDI)

by Advanced Medical Associates, Llc

Identity

Trade Name
Areza Medical FDA UDI
Generic Name
Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Device Name
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. FDA UDI
Model / Reference
F5410 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
F5410 FDA UDI
Primary DI / UDI-DI
00850021481902 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 5 Inch FDA UDI
Width — 4 Inch FDA UDI

Category: Wound-nonadherent dressing, absorbent, non-antimicrobial

Areza Medical by Advanced Medical Associates, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Medical Associates, Llc

Sources (1)

  • FDA UDI fb2e4d64-a10d-4a57-ad4c-fce19cbcee97 37 fields · synced May 30, 2026