AccessGUDID - DEVICE: MR Patient Care Neonatal ECG 3.0 Cable IEC (00884838121171)

GUDID

Device Identifier (DI) Information

Brand Name: MR Patient Care Neonatal ECG 3.0 Cable IEC
Version or Model: Neonatal ECG 3.0 Cable IEC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803193771
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838121171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: ECG lead cable designed for use with 3rd-generation wireless ECG module and Neonatal Quadtrodes (IEC coded leads.)

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:	No
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?
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or cable with connector. Some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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 -20 and 60 Degrees Celsius
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 570 and 1020 millibar
Storage Environment Atmospheric Pressure: between 57 and 102 KiloPascal
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
No Device Sizes

Device Record Status

Public Device Record Key: 07198252-8359-4dbb-a9c7-89924b64ad5d
Public Version Date: May 28, 2025
Public Version Number: 1
DI Record Publish Date: May 20, 2025