Primary Device ID | 00860006348007 |
NIH Device Record Key | 5930d07f-7fa8-41f0-b2df-3bd16c5bbe50 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASCEND Catalyst Live |
Version Model Number | 7.2 |
Company DUNS | 092700132 |
Company Name | Ascend Cardiovascular LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860006348007 [Primary] |
OUG | Medical Device Data System |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-04 |
Device Publish Date | 2023-09-26 |
00860006348014 - ASCEND InView | 2024-10-30 ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to display medical images. The ASCEN |
00860006348007 - ASCEND Catalyst Live | 2023-10-04Catalyst Live is a telepresence solution that enables collaboration in imaging, surgical, remote, and hybrid environments. |
00860006348007 - ASCEND Catalyst Live | 2023-10-04 Catalyst Live is a telepresence solution that enables collaboration in imaging, surgical, remote, and hybrid environments. |
00860006348021 - ASCEND InView | 2023-10-04 InView automatically categorizes adult Transthoracic Echo (TTE) images by view/modality, reorganizes images according to relevan |