Areza Medical
Basic Information
- Brand Name
- Areza Medical
- Primary DI
- 00850021481001
- Version / Model
- SSF91010
- Catalog Number
- SSF91010
- Company Name
- ADVANCED MEDICAL ASSOCIATES, LLC
- Labeler DUNS
- 047724226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2024-10-26
- Public Version
- 1
- Public Version Date
- 2024-11-04
- Public Version Status
- New
- Public Device Record Key
- 85b8c2f1-fc8a-49d4-a042-512dc18f537c
Device Description
Areza Sacral Ultra-Absorbent Foam with Adhesive Border and Flaps consists of a fenestrated silicone wound contact layer, a triple-layer ultra-absorbent pad, and a vapor permeable, waterproof polyurethane (PU) film backing. The multi-layer construction facilitates dynamic fluid management to provide an optimal moist wound environment known to promote faster wound healing. Dynamic fluid management may help reduce the risk of maceration. The gentle silicone layer can significantly minimize pain and trauma to the wound and its surrounding skin during dressing change. The two main absorbent layers- PU foam and ultra-absorbent polyacrylate, provide superior absorption and lock exudates away. The PU backing is waterproof and vapor permeable and may protect against contaminations by external fluids and organisms.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAD | Dressing, Wound, Occlusive | General, Plastic Surgery | 878.4020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850021481957 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00850021481001 | GS1 | ||||
| Unit of Use | 00850021481353 | GS1 |
Customer Contacts
- Phone
- (214) 356-8716
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 9.1 | Inch | |
| Width | 10.2 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place. Avoid excessive heat