DEVICE: CARESCAPE ONE (00195278288639)
Device Identifier (DI) Information
CARESCAPE ONE
MBZ323
In Commercial Distribution
2087075-300
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
MBZ323
In Commercial Distribution
2087075-300
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CARESCAPE ONE MBZ323 ATO MODEL
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 36872 | Multiple vital physiological parameter monitoring system, clinical |
An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DQK | Computer, diagnostic, programmable |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| MUD | Oximeter, tissue saturation |
| DPZ | Oximeter, ear |
| FLL | Thermometer, electronic, clinical |
| DSK | COMPUTER, BLOOD-PRESSURE |
| DPS | Electrocardiograph |
| DXN | System, measurement, blood-pressure, non-invasive |
| QEM | Cerebral oximeter |
| DSJ | Alarm, blood-pressure |
| BZQ | Monitor, breathing frequency |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| DQA | Oximeter |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K213234 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -30 and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure: between 50 and 108 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
ffba618d-4b4c-4f9d-8c65-be7f54bf9507
May 25, 2022
2
May 13, 2022
May 25, 2022
2
May 13, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined