Hygea Sterile Saline Wipe

Basic Information

• Brand Name: Hygea Sterile Saline Wipe
• Primary DI: 00310819000307
• Version / Model: C22370
• Catalog Number: C22370
• Company Name: PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
• Labeler DUNS: 800777117
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-03
• Public Version: 1
• Public Version Date: 2020-08-11
• Public Version Status: New
• Public Device Record Key: 0ac5923d-85d4-4377-98c1-a982364f18b7

Device Description

Wipe used for cleansing with a sterile saline solution where indicated

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61695	Skin-cleaning wipe, sterile	A sterile device consisting of an absorbent fabric pre-soaked in a liquid solution (e.g. a detergent, alcohol, saline) 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	10310819000304	GS1	box	24	In Commercial Distribution
Primary	00310819000307	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	6	Inch
Width	4	Inch