Hypotension Decision Assist (HDA)
Basic Information
- Brand Name
- Hypotension Decision Assist (HDA)
- Primary DI
- 00860003496718
- Version / Model
- HDA-OR2
- Company Name
- DIRECTED SYSTEMS LIMITED
- Labeler DUNS
- 226613470
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-04
- Public Version
- 2
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 0ebda358-cac7-4392-8a84-fb833bc1a2d2
Device Description
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | Cardiovascular | 870.1435 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61087 | Clinical management support software | An 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, post-therapy prognosis/risk score, anaesthesia/pharmaceutical dosage, and/or links to guidelines) to a healthcare professional responsible for patient care; it is not primarily intended to analyse or manage diagnostic/patient images. Otherwise known as clinical decision support (CDS) software, it may be a locally-installed program, web-based, or mobile application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860003496718 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212529 | 000 |