FDA.reportPublic FDA data

Analytic for Hemodynamic Instability

Primary DI
B823AHIP100
Brand
Analytic for Hemodynamic Instability
Company
Fifth Eye, Inc.
Model
P1
Device description
Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
Published
2021-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QNVAdjunctive Hemodynamic Indicator With Decision Point

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QNVAdjunctive Hemodynamic Indicator With Decision PointCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200022000Analytic for Hemodynamic Instability (AHI)Fifth Eye, Inc.2021-03-01QNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B823AHIP100PrimaryHIBCC0

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, suggestions, 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
B823AHIV200AHI System22022-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B823AHIV200AHI SystemFifth Eye, Inc.QNV2022-02-12