CONMED

Basic Information

• Brand Name: CONMED
• Primary DI: 20653405022371
• Version / Model: FSP2 18-003R
• Catalog Number: FSP2 18-003R
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2020-10-22
• Public Version: 3
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 1e8d2620-90d7-4f5d-b2b6-fb38c0ffdf66

Device Description

ECG Leadwires

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
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
Previous	30653405022378	GS1
Primary	20653405022371	GS1
Unit of Use	00653405022377	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K933649	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 95 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius