AccessGUDID - DEVICE: Areza Medical (00850021481278)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: FADWR6.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FADWR6.5
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in dry, cool place. Avoid excessive heat.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de071d35-f1c2-43ab-8206-6ebf6290fdec
Public Version Date: September 30, 2022
Public Version Number: 2
DI Record Publish Date: October 27, 2020