AHI System

Basic Information

• Brand Name: AHI System
• Primary DI: B823AHIV200
• Version / Model: 2
• Company Name: Fifth Eye, Inc.
• Labeler DUNS: 081336754
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-12
• Public Version: 5
• Public Version Date: 2024-10-21
• Public Version Status: Update
• Public Device Record Key: 3e5668ff-67dd-4ef0-b72b-b4984a8b4984

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QNV	Adjunctive Hemodynamic Indicator With Decision Point	Cardiovascular	870.2220	2
QNL	Medium-Term Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	870.2210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61087	Clinical management support software	An application software program intended to facilitate clinical management decisions by receiving patient data from electronic health records and/or manually-entered information (e.g., demographics, diagnostic/laboratory results) and returning clinical care information (e.g., reports, referral pathways, pedigree diagrams, reminders, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Also known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B823AHIV200	HIBCC