MEDALink

Basic Information

• Brand Name: MEDALink
• Primary DI: G096MMR5VPR0500
• Version / Model: M-MR-5VPR-050
• Catalog Number: M-MR-5VPR-050
• Company Name: Rising Eagle Medical LLC
• Labeler DUNS: 080145608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-27
• Public Version: 1
• Public Version Date: 2024-08-05
• Public Version Status: New
• Public Device Record Key: 310cd5f0-c0dc-4843-bc5b-92e12e0b30f3

Device Description

5 VLead, Pinch, Reusable, Mindray Compatible, 50in, ECG Leadwire, AHA/AAMI, 1/EA

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
IKD	Cable, Electrode	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G096MMR5VPR0500	HIBCC