MediMax Tech

Basic Information

• Brand Name: MediMax Tech
• Primary DI: 00817325022736
• Version / Model: MXC55R-3 ECG
• Company Name: MEDIMAX TECH INC.
• Labeler DUNS: 927071162
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 5
• Public Version Date: 2018-12-31
• Public Version Status: Update
• Public Device Record Key: 318c4b7b-d5db-4860-aa24-6ae09f001f79
• Distribution End Date: 2018-12-31

Device Description

MXC55R-3 ECG: Cloth, Round 55mm, Solid Gel, ECG Electrode, 3pcs/Pack, 60pcs/Box, 600pcs/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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
DRX	Electrode, Electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817325022736	GS1
Package	10817325022733	GS1	Inner Box	20	Not in Commercial Distribution	2018-12-31
Package	20817325022730	GS1	Master Case	10	Not in Commercial Distribution	2018-12-31

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020003	000