AccessGUDID - DEVICE: Protect U Guard Flexible Fabric Adhesive Bandages (B086191421)

GUDID

Device Identifier (DI) Information

Brand Name: Protect U Guard Flexible Fabric Adhesive Bandages
Version or Model: P19142
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROTECT U GUARD, LLC

Primary DI Number: B086191421
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 080070945 *Terms of Use

Device Description: Protect U Guard Flexible Fabric Adhesive Bandages Round 2.5cm

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?
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Circumference: 25 Millimeter

Device Record Status

Public Device Record Key: a1c18ae6-584e-42f1-bd68-735fd2461150
Public Version Date: August 31, 2020
Public Version Number: 1
DI Record Publish Date: August 21, 2020