BodyMed

Basic Information

• Brand Name: BodyMed
• Primary DI: 00815802010115
• Version / Model: ZZA45LW
• Catalog Number: ZZA45LW
• Company Name: BOXOUT, LLC
• Labeler DUNS: 066689993
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 3
• Public Version Date: 2020-02-27
• Public Version Status: Update
• Public Device Record Key: ce57c6b6-8a1d-4e53-86ff-6be1ca354a63

Device Description

BODYMED REPLACEMENT LEAD WIRES, 2/PK, for BODYMED TENS UNIT

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: Yes
• 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
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	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
Package	20815802010119	GS1	Master carton	500	In Commercial Distribution
Primary	00815802010115	GS1

Customer Contacts

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