ComforTENS Plus

Basic Information

• Brand Name: ComforTENS Plus
• Primary DI: 90884521162910
• Version / Model: MU73495
• Catalog Number: MU73495
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 48
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 8
• Public Version Date: 2020-10-12
• Public Version Status: Update
• Public Device Record Key: 44365ea2-c49a-4fae-90e1-f88623bc759b

Device Description

True content to be populated as part of rebranding

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: 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
GXY	ELECTRODE, CUTANEOUS	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35751	Transcutaneous electrical stimulation lead	A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	90884521162910	GS1
Unit of Use	10884521535947	GS1

Customer Contacts

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