AccessGUDID - DEVICE: True Comfort Alcohol Pads (00860000526517)

GUDID

Device Identifier (DI) Information

Brand Name: True Comfort Alcohol Pads
Version or Model: 6517
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HOME AIDE DIAGNOSTICS, INC.

Primary DI Number: 00860000526517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 783518983 *Terms of Use

Device Description: • 2-ply pads • Saturated with 70% isopropyl alcohol • 100 individually packed alcohol pads per box • For external use only

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?
61694	Skin cleaning wipe	A device consisting of an absorbent fabric pre-soaked in a liquid solution [e.g., with a detergent, alcohol, saline, hyaluronic acid (HA), plant extracts] intended for cleaning a localized body surface before a procedure or device application, and/or to maintain skin hygiene. It is commonly known as a wet wipe and 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
LKB	Pad, Alcohol, Device Disinfectant

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65f61810-d2fa-45a8-9460-143dcc1ad51b
Public Version Date: October 16, 2024
Public Version Number: 1
DI Record Publish Date: October 08, 2024