Areza Medical
Basic Information
- Brand Name
- Areza Medical
- Primary DI
- 00850021481278
- Version / Model
- FADWR6.5
- Catalog Number
- FADWR6.5
- Company Name
- ADVANCED MEDICAL ASSOCIATES, LLC
- Labeler DUNS
- 047724226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2020-10-27
- Public Version
- 2
- Public Version Date
- 2022-09-30
- Public Version Status
- Update
- Public Device Record Key
- de071d35-f1c2-43ab-8206-6ebf6290fdec
Device Description
Areza Foam Dressing with Adhesive Border 6.5” x 6.5” is composed of three layers: 1- a central polyurethane (PU) foam pad with a size of 4.1” x 4.1” and 5 mm thickness. Foam pad to lay on exuding wounds and is non-adhesive as long as it is used on actively exuding wounds. 2- a very thin PU backing layer which is soft, white in color, breathable, and reinforced with Spunlace, nonwoven fabric mesh. Note: this layer provides water resistance, but it is not waterproof. Meaning liquid may cross from the outer surface to the inside with some delay (normally about 10-20 mins or longer). Unless the foam is soaked, exudate does not cross from the inner surface to outer surface. This dressing is not suitable for showering or swimming. 3- an adhesive layer composed of medical grade Henkel glue that is adhered onto the second layer, the Spunlace, nonwoven fabric mesh.
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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00850021481285 | GS1 | ||||
| Primary | 00850021481278 | GS1 |
Customer Contacts
- Phone
- 877-931-1387
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in dry, cool place. Avoid excessive heat.