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 to experience 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
Rx
false
OTC
false
Sterile
false
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B823AHIV200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical decision management support softwareAn 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, guidelines links) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. It may also be referred to as clinical decision support (CDS) software, and may be a locally-installed program, web-based, or mobile app.

Regulatory Flags#

DUNS number
081336754
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B823AHIP100Analytic for Hemodynamic InstabilityP12021-05-10

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 InstabilityFifth Eye, Inc.QNV2021-05-10