AccessGUDID - DEVICE: Areza Medical (00850021481575)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: CA4420
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CA4420
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481575
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

Device Description: Calcium Alginate Wound Dressing (20) - Areza Calcium Alginate is made of natural fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering through a process of ion exchange over the wound, maintaining a moist environment for wound healing. They are soft and conformable, easy to pack, tuck or apply over irregular-shaped wounds. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Indicated for wounds with moderate to heavy exudate, such as pressure ulcers, infected wounds, and venous insufficiency ulcers. Alginates require a secondary dressing to be secured on the wound.

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":	No
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: Cool, dry place. Avoid excessive heat

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 95198c4d-09aa-4be6-97fe-e86dd8cc8bfe
Public Version Date: October 17, 2022
Public Version Number: 1
DI Record Publish Date: October 07, 2022