MediMax Tech

Basic Information

• Brand Name: MediMax Tech
• Primary DI: 00817325021630
• Version / Model: MXNSR15L Neonatal Electrodes
• Company Name: MEDIMAX TECH INC.
• Labeler DUNS: 927071162
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 742c8fb2-477d-4ef1-bd97-0447dacc3e05

Device Description

MXNSR15L: Neonatal ECG Electrodes, 22x36mm Size, Radiolucent, 3pcs/pack, 300pcs/box, 3,000pcs/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
17460	Neonatal electrocardiographic electrode	A non-sterile electrical conductor applied to a neonatal patient to transmit electrical signals from the body surface to a data measuring/display device (typicaly an electrocardiograph, patient monitor, or patient monitoring system) to produce an electrocardiogram (ECG). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817325021630	GS1
Package	10817325021637	GS1	Inner Box	100	In Commercial Distribution
Package	20817325021634	GS1	Master Case	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053011	000