Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Calcium Alginate Wound Dressing (20) - Areza Calcium Alginate is made of natural fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering through a process of ion exchange over the wound, maintaining a moist environment for wound healing. They are soft and conformable, easy to pack, tuck or apply over irregular-shaped wounds. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Indicated for wounds with moderate to heavy exudate, such as pressure ulcers, infected wounds, and venous insufficiency ulcers. Alginates require a secondary dressing to be secured on the wound. FDA UDI
- Model / Reference
- CA4420 FDA UDI
- Description
- Calcium Alginate Wound Dressing (20) - Areza Calcium Alginate is made of natural fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering through a process of ion exchange over the wound, maintaining a moist environment for wound healing. They are soft and conformable, easy to pack, tuck or apply over irregular-shaped wounds. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Indicated for wounds with moderate to heavy exudate, such as pressure ulcers, infected wounds, and venous insufficiency ulcers. Alginates require a secondary dressing to be secured on the wound. FDA UDI
Identifiers
- Catalog Number
- CA4420 FDA UDI
- Primary DI / UDI-DI
- 00850021481575 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
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
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Advanced Medical Associates, Llc
Sources (1)
- FDA UDI 95198c4d-09aa-4be6-97fe-e86dd8cc8bfe 36 fields · synced May 29, 2026