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FDA UDI In Commercial Distribution 🇺🇸 United States

MR Patient Care Neonatal ECG Electrodes (25)

DI: 10884838117850 · Model: Neonatal ECG Electrodes (25) · Philips Medizin Systeme Böblingen GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

25

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Basic Information

Brand Name: MR Patient Care Neonatal ECG Electrodes (25)
Primary DI: 10884838117850
Version / Model: Neonatal ECG Electrodes (25)
Catalog Number: 989803179051
Company Name: Philips Medizin Systeme Böblingen GmbH
Labeler DUNS: 314101143
Distribution Status: In Commercial Distribution
Device Count in Pkg: 25
Record Status: Published
Publish Date: 2025-05-21
Public Version: 2
Public Version Date: 2026-03-02
Public Version Status: Update
Public Device Record Key: a6055f38-3890-4707-ac33-2377065bc517

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: Yes
PM Exempt: Yes
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
Unit of Use	00884838117853	GS1
Primary	10884838117850	GS1

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -40 – 122 Degrees Fahrenheit
Type: Storage Environment Humidity
Temperature Range: 5 – 80 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -40 – 50 Degrees Celsius