Sickbay Clinical Platform
Basic Information
- Brand Name
- Sickbay Clinical Platform
- Primary DI
- B693SICKBAY0301200
- Version / Model
- 3.1.20.
- Company Name
- Medical Informatics Corp.
- Labeler DUNS
- 014363314
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-11
- Public Version
- 3
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- 1295b2b0-fc71-4fef-bf83-e86806afe7ed
Device Description
Sickbay Clinical Platform is a software product that is intended to run on hospital servers on a hospital’s secure network. It gathers and stores all the physiological sensor data from patients admitted to the ER or ICU and is capable of re-displaying all the physiological sensor data in real-time when gathered or at any later time. The Sickbay Clinical Platform can be thought of as three distinct subsystems working together. The first subsystem is called the Sickbay Informatics server. This component does most of the work involving acquisition and archiving physiological data, executing data processing and data management functionality, and serving data on request to clients. The second component of sickbay is a database. The database is used to organize all of the relationships between data on the sickbay system. The third component of the Sickbay Clinical Platform is a web-server used for data visualization.
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57967 | Medical equipment clinical data interfacing software | An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B693SICKBAY0301200 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143304 | 000 |