MR Patient Care Neonatal ECG Electrodes (25)

Basic Information

• Brand Name: MR Patient Care Neonatal ECG Electrodes (25)
• Primary DI: 10884838101941
• Version / Model: Neonatal ECG Electrodes (25)
• Catalog Number: 989803179051
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2021-05-18
• Public Version: 5
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: b12336bf-159f-4b18-9851-b349e2720c1e

Device Description

ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX

Device Characteristics

• Single Use: Yes
• 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 Conditional
• 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	10884838101941	GS1
Unit of Use	00884838101944	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	77.700	Millimeter
Width	77.700	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 89 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 570 – 1020 millibar
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 429 – 765 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 5 – 80 Percent (%) Relative Humidity