Primary Device ID | 00860006348014 |
NIH Device Record Key | 2614da58-4395-46ce-b38f-6c869120a2c4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ASCEND InView |
Version Model Number | 9.5 |
Company DUNS | 092700132 |
Company Name | Ascend Cardiovascular LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | false |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com | |
Phone | 8444132610 |
information@ascendcv.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860006348014 [Primary] |
GS1 | 00860006348021 [Previous] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-30 |
Device Publish Date | 2024-10-22 |
00860006348021 | InView automatically categorizes adult Transthoracic Echo (TTE) images by view/modality, reorgan |
00860006348014 | ASCEND InView v9.5 is a software-only medical device intended for use by trained clinicians to d |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ASCEND INVIEW 88710358 not registered Live/Pending |
Ascend Hit LLC 2019-11-29 |