Patient Lead Wire Adapter Set

Basic Information

• Brand Name: Patient Lead Wire Adapter Set
• Primary DI: 00817266020778
• Version / Model: 41431
• Company Name: MERIT CABLES INCORPORATED
• Labeler DUNS: 180587883
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-09
• Public Version: 3
• Public Version Date: 2022-01-03
• Public Version Status: Update
• Public Device Record Key: ac7d2249-a82e-4660-95ff-b9b29de65a6a

Device Description

Lead wire adapter set - NIKOMED 10 pack

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	870.2900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35562	Electrocardiographic lead set, reusable	A collection of 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 (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	00817266020778	GS1

Premarket Submissions

Submission Number	Supplement Number
K942321	000