DEVICE: Areza Medical (00850021481902)

Device Identifier (DI) Information

Areza Medical
F5410
In Commercial Distribution
F5410
ADVANCED MEDICAL ASSOCIATES, LLC
00850021481902
GS1

10
047724226 *Terms of Use
Areza Foam Dressing is a sterile, disposable, soft, and highly absorbent foam dressing composed of polyurethane (PU) with a waterproof PU film backing, which may act as a physical barrier to infectious contaminants. Its design consists of small, open cells with a high absorptive capability making this dressing ideal for excessive exuding wounds. The dressing maintains a moist environment, ideal for wound healing, while also decreasing maceration to the surrounding, peri-wound, skin. The area in contact with the wound surface is non-adhesive for easy removal as long as the foam is moist. The part of the dressing that faces the wound has a small risk of adhering to wound surface if the wound is bleeding and/or has a low exudate. It is ideal to be used in partial and full-thickness wounds.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, Wound, Occlusive
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place. Avoid excessive heat
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 5 Inch
Width: 4 Inch
CLOSE

Device Record Status

fb2e4d64-a10d-4a57-ad4c-fce19cbcee97
November 04, 2024
1
October 26, 2024
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00850021481926 16 00850021481902 In Commercial Distribution Inner case
00850021481933 32 00850021481902 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00850021481322 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
(214) 356-8716
info@arezamedical.com
CLOSE