DEVICE: Areza Medical (00850021481056)
Device Identifier (DI) Information
Areza Medical
44220
In Commercial Distribution
44220
ADVANCED MEDICAL ASSOCIATES, LLC
44220
In Commercial Distribution
44220
ADVANCED MEDICAL ASSOCIATES, LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NAD | Dressing, Wound, Occlusive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in dry, cool environment. Avoid excessive heat. |
Clinically Relevant Size
[?]Size Type Text |
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Circumference: 23.88 Centimeter |
Device Record Status
f41ad0fe-bf03-41e5-93d9-c665c74d5a10
November 04, 2020
1
October 27, 2020
November 04, 2020
1
October 27, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00850021481223
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-931-1387
info@arezamedical.com
info@arezamedical.com