AHI System

FDA UDI

Class II (US FDA UDI)

by Fifth Eye, Inc.

Identity

Trade Name: AHI System FDA UDI
Generic Name: Clinical management support software FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 2 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: B823AHIV200 FDA UDI
FDA Product Code: QNV FDA UDI
QNL FDA UDI
GMDN Term: Clinical management support software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2220 FDA UDI
870.2210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Clinical management support software

AHI System by Fifth Eye, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Fifth Eye, Inc.

Sources (1)

FDA UDI 3e5668ff-67dd-4ef0-b72b-b4984a8b4984 33 fields · synced May 29, 2026