AccessGUDID - DEVICE: KODEX-EPD System (00884838095229)

GUDID

Device Identifier (DI) Information

Brand Name: KODEX-EPD System
Version or Model: 733015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838095229
Issuing Agency: GS1
Commercial Distribution End Date: October 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: The KODEX-EPD™ System is indicated for catheter-based cardiac electrophysiological (EP) procedures. The KODEX-EPD™ System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure.

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:	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?
44783	Cardiac mapping system application software	An individual software program or group of programs, routines and/or algorithms that add specific image processing and/or analysis capabilities to a cardiac mapping system computer for storing, processing and management of electronic information/data used to interpret cardiac physiology parameters. It is a basic set of application programs and routines used for cardiac mapping computer-controlled imaging which can be upgraded to correct programming errors or to add new system capabilities. An application program package is typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180940	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6933bc5-edbc-45d4-a7cd-1158eab621b9
Public Version Date: September 26, 2023
Public Version Number: 2
DI Record Publish Date: October 15, 2021