AccessGUDID - DEVICE: Areza Medical (00850021481179)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: 21209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TF22100
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481179
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

Device Description: Transparent Adhesive Film 2 3/8" x 2 3/4" (100) consist of a thin polyurethane (PU) film, with a hypoallergenic, latex-free, adhesive that gently, yet securely, adheres to skin. They are breathable, sterile, transparent, and water-resistant. May be used as a primary or secondary dressing over skin wounds and areas with fragile skin providing a barrier to external contaminants.

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?
58301	Synthetic polymer semi-permeable film dressing, adhesive	A transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, water) and/or promote healing. It is a thin, clear film made of synthetic polymer material that is covered on one side with a pressure-sensitive adhesive. It may be applied directly to tissue or used in combination with other dressings (e.g., gauze) to protect postsurgical incisions and minor wounds (e.g., cuts, scrapes, burns, skin tears, blisters). It may also be used to secure to skin other devices such as vascular catheters, infusion ports, or tubing. 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
Length: 2.375 Inch
Width: 2.75 Inch

Device Record Status

Public Device Record Key: cc9a68c3-8c21-48d2-8a0d-9e0aef220830
Public Version Date: October 14, 2024
Public Version Number: 4
DI Record Publish Date: October 26, 2020