MediMax Tech

Basic Information

• Brand Name: MediMax Tech
• Primary DI: 00817325021647
• Version / Model: Leadwires (Set)
• Company Name: MEDIMAX TECH INC.
• Labeler DUNS: 927071162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-08
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8cf76685-3fcb-4c97-b515-9e0c90437112

Device Description

Leadwires (Set) - Tens/EMS/IF Unit Leadwires, 2 sets, 48'', Safety Plug, Black & Red Coloring Wires, 500 Sets/ Master Case

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	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	20817325021641	GS1	Master Case	2	In Commercial Distribution
Package	10817325021644	GS1	Inner Box	250	In Commercial Distribution
Primary	00817325021647	GS1

Customer Contacts

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