AccessGUDID - DEVICE: ASCEND Catalyst Live (00860006348007)

GUDID

Device Identifier (DI) Information

Brand Name: ASCEND Catalyst Live
Version or Model: 7.2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ascend Cardiovascular LLC

Primary DI Number: 00860006348007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092700132 *Terms of Use

Device Description: Catalyst Live is a telepresence solution that enables collaboration in imaging, surgical, remote, and hybrid environments.

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):	No
Over the Counter (OTC):	Yes
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?
63383	Video consultation telemedicine system	A electrically-powered device designed for use in telemedicine to provide real-time and interactive transmission of images and sound between two or more sites, enabling a healthcare professional to communicate with other professionals or directly with a patient. It consists of VDU, camera, speaker, and headphone components that may be integrated (or attached to) a mobile or hand-held unit which has rechargeable batteries, or as components that can be connected to a television; there may be optional accessories to provide additional functionality (e.g., stethoscope). It can be used within or between healthcare facilities, or a professional facility and the home.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 5930d07f-7fa8-41f0-b2df-3bd16c5bbe50
Public Version Date: October 22, 2024
Public Version Number: 2
DI Record Publish Date: September 26, 2023