Analytic for Hemodynamic Instability

FDA UDI

Class II (US FDA UDI)

by Fifth Eye, Inc.

Identity

Trade Name: Analytic for Hemodynamic Instability FDA UDI
Generic Name: Clinical management support software FDA UDI
Device Name: Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making FDA UDI
Model / Reference: P1 FDA UDI
Description: Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making FDA UDI

Identifiers

Primary DI / UDI-DI: B823AHIP100 FDA UDI
510(k) Number: DEN200022 FDA UDI
FDA Product Code: QNV FDA UDI
GMDN Term: Clinical management support software FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2220 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

Analytic for Hemodynamic Instability by Fifth Eye, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Clinical management support software.

DentalMonitoring - Smile Doctors — Dental Monitoring · Class II
SIR-Spheres® Microspheres Activity Calculator (SMAC) — SIRTEX MEDICAL PTY LTD · Class II
AWARE — Ambient Clinical Analytics · Class II
BioDashboard — BIOINTELLISENSE, INC. · Class II
Vinehealth Cancer Companion — VINEHEALTH DIGITAL LIMITED · Class I
Glooko Mobile Insulin Dosing (MIDS) on Glooko WebDashboard — Glooko, Inc. · Class II
Vios Monitoring System Central Station Monitor — Murata Vios, Inc. · Class I
Vios Monitoring System Mobile Application — Murata Vios, Inc. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Fifth Eye, Inc.

Sources (1)

FDA UDI bd099ea1-fab5-4697-9677-9c8a3069869d 34 fields · synced May 31, 2026