Advantage Medical Cable ECG Leads

Basic Information

• Brand Name: Advantage Medical Cable ECG Leads
• Primary DI: 00816317023225
• Version / Model: RM-LW-209DS50/3A
• Company Name: RENU MEDICAL, INC
• Labeler DUNS: 100439103
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-16
• Public Version: 4
• Public Version Date: 2023-09-08
• Public Version Status: Update
• Public Device Record Key: e0afa280-8f61-4e0b-91fa-e06c89141464

Device Description

AMC - Disp. 3 Lead DIN to Snap Leadset

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
61812	Electrocardiographic lead set, reprocessed	A collection of non-sterile, noninvasive devices intended to be used 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 includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array to assist electrode placement. It is not designed with radiolucent properties. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10816317023222	GS1		25	In Commercial Distribution
Primary	00816317023225	GS1