Kosmos ECG Patient Cable - International

Basic Information

• Brand Name: Kosmos ECG Patient Cable - International
• Primary DI: 09353278000243
• Version / Model: P006186
• Company Name: ECHONOUS, INC.
• Labeler DUNS: 080481089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-06
• Public Version: 2
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 2b61dd0a-bf38-41d6-be02-9002ba2b790b

Device Description

Electrocardiograph, professional, single-channel Electrocardiographic lead set, reusable

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: 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
DPS	Electrocardiograph	Cardiovascular	870.2340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11413	Electrocardiograph, professional, single-channel	A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.	No	Active
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	09353278000243	GS1

Premarket Submissions

Submission Number	Supplement Number
K193518	000