ECG Electrodes

Basic Information

• Brand Name: ECG Electrodes
• Primary DI: 20884838013494
• Version / Model: CBL ECG 5 LEAD GRABBER, AAMI, SPU, TELE
• Catalog Number: 989803172031
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 7
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 85dfd90a-80ed-4135-9a44-9acd401ec959

Device Description

MX40 Patient Cable consists of 5-wire ECG lead set. Grabber leads, AAMI color coded (white mono color lead wires). Single Patient Use. Cable length = 85 cm (33.5 .) 1 Sales unit= 20 patient cables.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	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	20884838013494	GS1
Unit of Use	00884838013490	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity