ECG Cables and Leadsets

Basic Information

• Brand Name: ECG Cables and Leadsets
• Primary DI: 20884838006755
• Version / Model: Preattached Leadwire Electrode, medium
• Catalog Number: 13952A
• Company Name: Philips Medical Systems Hsg
• Labeler DUNS: 790605856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-12-27
• Public Version: 9
• Public Version Date: 2022-09-21
• Public Version Status: Update
• Public Device Record Key: 1a50a023-609e-4cab-b962-b05efb37843d

Device Description

Preattached Leadwire Electrode, medium Metallic copper AAMI color 45cm/18" leadwires with 1.5mm/.060" safety socket rectangular 33cm x 22cm cloth backing with Ag/AgCl sensor, 3/pouch, 300 case.

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DRX	Electrode, electrocardiograph	Cardiovascular	870.2360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35035	Electrocardiographic electrode, single-use	A non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20884838006755	GS1
Unit of Use	10884838006758	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 100 Percent (%) Relative Humidity