| 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 |