Tens 7000 Conductive Sleeves

Basic Information

• Brand Name: Tens 7000 Conductive Sleeves
• Primary DI: 00092237622049
• Version / Model: DT7202-SLEEVE
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-11-20
• Public Version: 4
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: a477aa7a-e7bc-4e57-80f5-a2257b75fee3

Device Description

Tens 7000 Conductive Sleeves includes (1) pair of sleeves, snap lead wires, insert and pack of 3" round electrodes

Device Characteristics

• Single Use: No
• 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: Yes
• 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
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	80092237622045	GS1	Master Carton	50	In Commercial Distribution
Primary	00092237622049	GS1
Unit of Use	01092237622048	GS1

Customer Contacts

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