NA

Basic Information

• Brand Name: NA
• Primary DI: 00884838014695
• Version / Model: 452230032863
• Catalog Number: 452230032863
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-11
• Public Version: 4
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: 34c88b67-3852-4df6-9314-c58b03082328
• Distribution End Date: 2018-12-15

Device Characteristics

• Single Use: No
• 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: 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
MWI	MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36038	Radiolucent electrocardiographic lead	A radiolucent insulated metal or non-metallic wire(s) with an electrode used to conduct electrical signals from a patient's heart, via the electrode which is attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine. It is typically used during cardiac catheterization procedures because it will cast a slight or negligible shadow on the radiographic images. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838014695	GS1

Customer Contacts

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