Primary Device ID | B823AHIP100 |
NIH Device Record Key | bd099ea1-fab5-4697-9677-9c8a3069869d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Analytic for Hemodynamic Instability |
Version Model Number | P1 |
Company DUNS | 081336754 |
Company Name | Fifth Eye, Inc. |
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 | true |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B823AHIP100 [Primary] |
QNV | Adjunctive Hemodynamic Indicator With Decision Point |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-05-18 |
Device Publish Date | 2021-05-10 |
B823AHIV200 - AHI System | 2022-02-21 The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic inst |
B823AHIP100 - Analytic for Hemodynamic Instability | 2021-05-18Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making |
B823AHIP100 - Analytic for Hemodynamic Instability | 2021-05-18 Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making |