Comfort Plus

Basic Information

• Brand Name: Comfort Plus
• Primary DI: 10075289064965
• Version / Model: CPR-500
• Catalog Number: CPR-500
• Company Name: TRANZONIC COMPANIES, THE
• Labeler DUNS: 007900020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2022-12-30
• Public Version: 3
• Public Version Date: 2023-06-15
• Public Version Status: Update
• Public Device Record Key: 7eb3d1a2-096a-469e-97c1-421b0a2544a0

Device Description

COMFORT PLUS PLASTIC APPLICATOR TAMPONS, REGULAR ABSORBANCY BULK 500/CS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
HEB	Tampon, Menstrual, Unscented	Obstetrics/Gynecology	884.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35694	Menstrual tampon, unscented	A non-deodorized plug made of cellulosic or synthetic material that is inserted into the vagina to absorb menstrual blood or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00075289064968	GS1
Primary	10075289064965	GS1

Customer Contacts

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