2XChromosome

Basic Information

• Brand Name: 2XChromosome
• Primary DI: 00850022610004
• Version / Model: (2X)200920WP
• Catalog Number: WBOZY008
• Company Name: Global Health Solutions LLC
• Labeler DUNS: 117588619
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-04-30
• Public Version: 2
• Public Version Date: 2022-08-01
• Public Version Status: Update
• Public Device Record Key: 132c771a-0286-49df-8e8c-f1d0b3297d44
• Distribution End Date: 2021-12-31

Device Description

Personal Care Cleansing Wipes; individually wrapped, organic cotton, alcohol free

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LRJ	Disinfectant, Medical Devices	General Hospital	880.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61694	Skin-cleaning wipe, non-sterile	A non-sterile 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850022610001	GS1		120	Not in Commercial Distribution	2021-12-31
Primary	00850022610004	GS1
Unit of Use	00850022610110	GS1