AccessGUDID - DEVICE: Analytic for Hemodynamic Instability (B823AHIP100)

GUDID

Device Identifier (DI) Information

Brand Name: Analytic for Hemodynamic Instability
Version or Model: P1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fifth Eye, Inc.

Primary DI Number: B823AHIP100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081336754 *Terms of Use

Device Description: Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61087	Clinical decision management support software	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QNV	Adjunctive Hemodynamic Indicator With Decision Point

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200022	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bd099ea1-fab5-4697-9677-9c8a3069869d
Public Version Date: July 21, 2026
Public Version Number: 5
DI Record Publish Date: May 10, 2021