AccessGUDID - DEVICE: EchoNavigator (00884838059283)

GUDID

Device Identifier (DI) Information

Brand Name: EchoNavigator
Version or Model: EchoNavigator - 2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 001011
Company Name: Philips Medical Systems Nederland B.V.

Primary DI Number: 00884838059283
Issuing Agency: GS1
Commercial Distribution End Date: November 03, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 413819707 *Terms of Use

Device Description: Software medical device. Assists the interventionalist and surgeon with image guidance during treatment of cardiovascular disease for which the procedure uses both live X-ray and live Echo guidance.

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?
40868	Angiographic x-ray system application software	An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to an x-ray fluoroscopy based imaging system including x-ray angiography system configurations. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some must be combined with specific hardware or firmware configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121781	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: f5d66a92-cd8c-46c5-b814-1d6dda81c820
Public Version Date: September 26, 2023
Public Version Number: 10
DI Record Publish Date: September 24, 2016