Hypotension Decision Assist (HDA) - Hypotension Decision Assist (HDA) is a clinical - DIRECTED SYSTEMS LIMITED

Duns Number:226613470

Device Description: Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Dev Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters.HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.

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More Product Details

Catalog Number

-

Brand Name

Hypotension Decision Assist (HDA)

Version/Model Number

HDA-OR1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190955

Product Code Details

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Device Record Status

Public Device Record Key

63d9e656-f31b-47e3-950e-66144cf39d63

Public Version Date

October 24, 2022

Public Version Number

3

DI Record Publish Date

June 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIRECTED SYSTEMS LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2