Identity
- Trade Name
- Areza Medical FDA UDI
- Generic Name
- Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
- Device Name
- Areza Silicone Foam Dressing for Ostomies consists of a fenestrated, self-adhering, silicone wound contact layer, an absorbent polyurethane (PU) foam pad layer, and a vapor permeable and waterproof polyurethane film backing. The triple-layer construction facilitates dynamic fluid management to provide optimal moist wound environment; and may help reduce the risk of maceration. The absorbent pad layer provides superior absorption locking away exudates. FDA UDI
- Model / Reference
- 44220 FDA UDI
- Description
- Areza Silicone Foam Dressing for Ostomies consists of a fenestrated, self-adhering, silicone wound contact layer, an absorbent polyurethane (PU) foam pad layer, and a vapor permeable and waterproof polyurethane film backing. The triple-layer construction facilitates dynamic fluid management to provide optimal moist wound environment; and may help reduce the risk of maceration. The absorbent pad layer provides superior absorption locking away exudates. FDA UDI
Identifiers
- Catalog Number
- 44220 FDA UDI
- Primary DI / UDI-DI
- 00850021481056 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
- Circumference — 23.88 Centimeter 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 f41ad0fe-bf03-41e5-93d9-c665c74d5a10 37 fields · synced Jun 1, 2026