AHI System

GUDID B823AHIV200

The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.

Fifth Eye, Inc.

Clinical management support software

• Primary Device ID: B823AHIV200
• NIH Device Record Key: 3e5668ff-67dd-4ef0-b72b-b4984a8b4984
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AHI System
• Version Model Number: 2
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B823AHIV200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212219

FDA Product Code

• QNV: Adjunctive Hemodynamic Indicator With Decision Point

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-21
• Device Publish Date: 2022-02-12

Devices Manufactured by Fifth Eye, Inc.

• B823AHIV200 - AHI System: 2022-02-21The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic instability or are likely to experience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
• 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: 2021-05-18 Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making