AccessGUDID - DEVICE: Areza Medical (00850021481094)

GUDID

Device Identifier (DI) Information

Brand Name: Areza Medical
Version or Model: FT2X1012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FT2X1012
Company Name: ADVANCED MEDICAL ASSOCIATES, LLC

Primary DI Number: 00850021481094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 047724226 *Terms of Use

Device Description: Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (12 Roll) is composed of a soft, porous, semi-occlusive fabric backing covered with an adhesive layer. This Fabripore adhesive tape is designed to decrease the risk of maceration while securing other dressings (primary) over wounds, catheters, tubings, electrodes, and any other device items that may need fixation. Conveniently perforated every 2 inches to be able to tear it by hand for easier handling. No latex is used in production.

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?
10284	Pressure bandage, non-latex, single-use	A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape And Bandage, Adhesive

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Length: 10 Yard

Device Record Status

Public Device Record Key: 017b4fa3-37e0-475a-8c27-55e1c81b2abe
Public Version Date: September 29, 2022
Public Version Number: 2
DI Record Publish Date: October 27, 2020