AccessGUDID - DEVICE: ECG Electrodes (20884838007868)

GUDID

Device Identifier (DI) Information

Brand Name: ECG Electrodes
Version or Model: DISP METALLIC 3 LEADWIRE ELECT SET, AAMI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803156201
Company Name: Philips Medical Systems Hsg

Primary DI Number: 20884838007868
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 790605856 *Terms of Use

Device Description: Disposable, adult, 3-lead ECG monitoring, solid gel electrodes with pre-attached 39 inch (100cm) non-shielded, copper, AAMI color-coded lead wires. Silver/silver chloride (Ag/AgCi) sensor, repositionable. Electrode is rectangular in shape and is 30 mm x 45 mm in size. Packaging is 1 set (3pcs.) per pouch or 100 sets (300 pcs) per box. Sold in box quantities only. For use with all adult ECG monitors; NOT for use with Philips Telemetry Transmitters and Transceivers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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 5 and 30 Degrees Celsius
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Storage Environment Humidity: between 0 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a1ba208-5619-4e70-8ce5-2b01b6eaf729
Public Version Date: April 02, 2024
Public Version Number: 8
DI Record Publish Date: January 06, 2017