Hypotension Decision Assist (HDA)

GUDID 00860003496718

Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen tablet computer. HDA-OR2 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-OR2 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-OR2 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.

DIRECTED SYSTEMS LIMITED

Clinical management support software

• Primary Device ID: 00860003496718
• NIH Device Record Key: 0ebda358-cac7-4392-8a84-fb833bc1a2d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypotension Decision Assist (HDA)
• Version Model Number: HDA-OR2
• Company DUNS: 226613470
• Company Name: DIRECTED SYSTEMS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003496718 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212529

FDA Product Code

• DXG: Computer, Diagnostic, Pre-Programmed, Single-Function

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-12
• Device Publish Date: 2022-01-04

On-Brand Devices [Hypotension Decision Assist (HDA)]

• 00860003496701: Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (S
• 00860003496718: Hypotension Decision Assist HDA-OR2 is a clinical decision support Software as a Medical Device