EEG Cables and Lead Sets

Basic Information

• Brand Name: EEG Cables and Lead Sets
• Primary DI: 00884838037939
• Version / Model: EEG CBL Lead Set Mini for 9 Elec.
• Catalog Number: 989803180531
• Company Name: Philips Medizin Systeme Böblingen GmbH
• Labeler DUNS: 314101143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-03
• Public Version: 6
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 82abda24-4b23-452e-9bdf-a986fcbf6365

Device Description

EEG Lead Set with 9 individual color coded leads for use on neonatal and pediatric patients. Lead wires comes with DIN connector on one end and hard mounted EEG silver clip electrodes on the other end. Individual leads are hold in place with a lead organizer. Silver clip diameter = 6 mm, 80 cm (31.5 in) long leads. Use with trunk cable 989803180541and conductive paste M1937A.

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
IKD	CABLE, ELECTRODE	Physical Medicine	890.1175	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35749	Analytical scalp lead	A wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or analysis during encephalography (EEG); the electrodes are not included. The procedure is performed to record, monitor, and/or analyse the brain's electrical activity. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838037939	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 10 – 107.5 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity