AccessGUDID - DEVICE: ECG Electrodes (00884838013377)

GUDID

Device Identifier (DI) Information

Brand Name: ECG Electrodes
Version or Model: CBL ECG 5 LEAD SNAPS, AAMI, TELE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803171821
Company Name: Philips Medical Systems Hsg

Primary DI Number: 00884838013377
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: MX40 Patient Cable consists of 5-wire ECG lead set. Snap leads, AAMI color coded (colored lead wires). Reusable. Cable length = 85 cm (33.5 .) 1 Sales unit= 1 cable.

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:	No
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 Temperature: between -40 and 60 Degrees Celsius
Storage Environment Temperature: between -40 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0b0ac77c-de98-4bf0-b8a0-ed60d92fd88e
Public Version Date: June 06, 2024
Public Version Number: 8
DI Record Publish Date: October 13, 2016