AHI System

Primary DI
B823AHIV200
Brand
AHI System
Company
Fifth Eye, Inc.
Model
2
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 toexperience a future episode of hemodynamic instability, and to allow clinicians an opportunity to increase vigilance.
Published
2022-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator
QNVAdjunctive Hemodynamic Indicator With Decision Point

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNLMedium-Term Adjunctive Predictive Cardiovascular IndicatorCardiovascular2
QNVAdjunctive Hemodynamic Indicator With Decision PointCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212219000AHI SystemFifth Eye, Inc.2021-12-03QNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B823AHIV200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical management support softwareAn application software program intended to facilitate clinical management decisions by receiving structured 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, pedigree diagrams, reminders, post-therapy prognosis/risk score, suggested pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. It is not primarily intended to manage diagnostic/patient images.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081336754
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B823AHIP100Analytic for Hemodynamic Instability P12021-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00690103219616ForeSight IQEdwards Lifesciences LLCQNL2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCQNL2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCQNL2025-07-11
00690103217957HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCQNL2025-03-13
07290018852002CLEWICUCLEW MEDICAL LTDQNL2024-12-09
03770025266015SignalHFImplicity Inc.QNL2024-04-16
B823AHIP100Analytic for Hemodynamic Instability Fifth Eye, Inc.QNV2021-05-10