Identity
- Trade Name
- Sickbay Clinical Platform FDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Sickbay Clinical Platform is a software product that is intended to run 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 data in real-time when gathered or at a later time. FDA UDI
- Model / Reference
- 3.1.21 FDA UDI
- Description
- Sickbay Clinical Platform is a software product that is intended to run 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 data in real-time when gathered or at a later time. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B693SICKBAY0301210 FDA UDI
- 510(k) Number
- K143304 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment clinical data interfacing software
Sickbay Clinical Platform by Medical Informatics Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Care Orchestrator — Respironics, Inc. · Class II
Cleared under the same submission
K143304 also covers:
- Sickbay Clinical Platform — Medical Informatics Corp
- Sickbay Clinical Platform — Medical Informatics Corp
- Sickbay Clinical Platform — Medical Informatics Corp
- Sickbay Clinical Platform — Medical Informatics Corp
- Sickbay Clinical Platform — Medical Informatics Corp
- Sickbay Clinical Platform — Medical Informatics Corp
- Sickbay Clinical Platform — Medical Informatics Corp
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medical Informatics Corp
Sources (1)
- FDA UDI f771895c-d636-4943-878e-839607797877 34 fields · synced May 31, 2026