AccessGUDID - DEVICE: MR Patient Care Neonatal ECG Electrodes (25) (10884838101941)

GUDID

Device Identifier (DI) Information

Brand Name: MR Patient Care Neonatal ECG Electrodes (25)
Version or Model: Neonatal ECG Electrodes (25)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803179051
Company Name: Philips Ds North America LLC

Primary DI Number: 10884838101941
Issuing Agency: GS1
Commercial Distribution End Date: June 16, 2025
Device Count: 25
Labeler D-U-N-S® Number*: 013649151 *Terms of Use
Previous DI: 20884838029549

Device Description: ELECTRODE, NEONATE MRI ECG, QUADTRODE CV, 25/BOX

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Length: 77.700 Millimeter
Width: 77.700 Millimeter

Device Record Status

Public Device Record Key: b12336bf-159f-4b18-9851-b349e2720c1e
Public Version Date: May 22, 2025
Public Version Number: 7
DI Record Publish Date: May 18, 2021