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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
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI
Device Name
Areza Carboxymethyl Cellulose (CMC) Gelling Fiber is a primary wound dressing made from medical-grade sodium carboxymethyl cellulose (CMC). The pad/dressing turns into a hydrophilic gel as it comes into contact with wound fluid (exudate). The newly formed gel is soft and provides an optimal moist wound healing environment, can conform to the wound bed, and by loosening the non-live material over the wound (autolytic debridement) reduces the need for physical debridement. Areza CMC gelling fiber absorbs the wound fluid in a very unique vertical direction called "vertical absorbency", a capability that may reduce the risk of maceration by reducing the horizontal spread of the wound fluid to the other parts of the dressing. This dressing is ideal for moderate to highly leaking (exuding) wounds. CMC also reduces the risk of infection by creating a physical barrier to external contaminants and microscopic organisms. The non-adhesive formed gel reduces the risk of wound trauma during dressing changes. FDA UDI
Model / Reference
CMC42520 FDA UDI
Description
Areza Carboxymethyl Cellulose (CMC) Gelling Fiber is a primary wound dressing made from medical-grade sodium carboxymethyl cellulose (CMC). The pad/dressing turns into a hydrophilic gel as it comes into contact with wound fluid (exudate). The newly formed gel is soft and provides an optimal moist wound healing environment, can conform to the wound bed, and by loosening the non-live material over the wound (autolytic debridement) reduces the need for physical debridement. Areza CMC gelling fiber absorbs the wound fluid in a very unique vertical direction called "vertical absorbency", a capability that may reduce the risk of maceration by reducing the horizontal spread of the wound fluid to the other parts of the dressing. This dressing is ideal for moderate to highly leaking (exuding) wounds. CMC also reduces the risk of infection by creating a physical barrier to external contaminants and microscopic organisms. The non-adhesive formed gel reduces the risk of wound trauma during dressing changes. FDA UDI

Identifiers

Catalog Number
CMC42520 FDA UDI
Primary DI / UDI-DI
00810147400546 FDA UDI
FDA Product Code
NAC FDA UDI
GMDN Term
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4018 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

No

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 — 4.25 Inch FDA UDI
Width — 4.25 Inch FDA UDI

Category: Exudate-absorbent dressing, hydrophilic-gel, 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 Exudate-absorbent dressing, hydrophilic-gel, 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 eac345ce-f262-4dcf-9f60-64b4d112b6f8 37 fields · synced May 30, 2026