Hypotension Decision Assist (HDA) - Hypotension Decision Assist HDA-OR2 is a clinical - DIRECTED SYSTEMS LIMITED

Duns Number:226613470

Device Description: Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical D Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon amedically-rated touch-screen tablet computer. HDA-OR2 connects to a multi-parameter patient monitor supplied by other manufacturers, fromwhich it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numericparameters. HDA-OR2 continually processes this data to display, in graphical charts and numeric format, vital signs data and derivedvariables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemicvascular resistance. HDA-OR2 compares MAP to user set targets to indicate when MAP is above or below the target range. It allowsthe 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-OR2

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

K212529

Product Code Details

Product Code

DXG

Product Code Name

Computer, Diagnostic, Pre-Programmed, Single-Function

Device Record Status

Public Device Record Key

0ebda358-cac7-4392-8a84-fb833bc1a2d2

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

January 04, 2022

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