AccessGUDID - DEVICE: ECG Electrodes (20884838013524)

GUDID

Device Identifier (DI) Information

Brand Name: ECG Electrodes
Version or Model: CBL ECG 5 LEAD GRABBER IEC+SPO2 SPU TELE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803172151
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838013524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: MX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/finger wrap sensor for patients (. 20 kg). Grabber leads, IEC color coded (white mono color lead wires). Single Patient Use. Cable length: ECG = 85 cm (33.5 .), SpO2 = 2m (6,5 ft) 1 Sales unit = 20 patient cables.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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
DSI	DETECTOR AND ALARM, ARRHYTHMIA

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 Atmospheric Pressure: between 10 and 108 KiloPascal
Storage Environment Temperature: between 12 and 35 Degrees Celsius
Storage Environment Temperature: between 53.6 and 95 Degrees Fahrenheit
Storage Environment Humidity: between 18 and 78 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d534e95e-e863-4d0f-9203-77fe705f9c58
Public Version Date: June 06, 2024
Public Version Number: 8
DI Record Publish Date: March 25, 2020