Primary Device ID | B720BX360TRIAGESTRO1120 |
NIH Device Record Key | d3f5687a-aa93-4357-832e-51958b02799f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Triage Stroke |
Version Model Number | 11.2 |
Company DUNS | 216967482 |
Company Name | BRAINOMIX LIMITED |
Device Count | 1 |
DM Exempt | false |
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 | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B720BX360TRIAGESTRO1120 [Primary] |
QAS | Radiological Computer-Assisted Triage And Notification Software |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-12-15 |
Device Publish Date | 2023-12-07 |
B720BX360ELUNG100 - e-Lung | 2024-06-24 |
B720BX360TRIAGESTRO1120 - Triage Stroke | 2023-12-15 |
B720BX360TRIAGESTRO1120 - Triage Stroke | 2023-12-15 |
B720BX360TRIAGELVO1110 - Triage LVO | 2023-10-11 |
B720BX360EMRI1110 - e-MRI | 2023-09-13 |
B720BX360TRIAGEICH1110 - Triage ICH | 2023-09-13 |
B720BX360ECTP1110 - e-CTP | 2023-07-14 |
B720BX360EASPECTS1110 - e-ASPECTS | 2023-04-14 |
B720BX360ECTA1110 - e-CTA | 2023-04-14 |