DEVICE: CARESCAPE Canvas D19 (00195278523365)
Device Identifier (DI) Information
CARESCAPE Canvas D19
5897061
In Commercial Distribution
5897061
GE Healthcare Finland Oy
5897061
In Commercial Distribution
5897061
GE Healthcare Finland Oy
CARESCAPE Canvas D19
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| No | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 36612 | Image display unit, colour |
An electrically-powered visual display unit (VDU), commonly known as a screen or a monitor [e.g., cathode-ray tube (CRT) or liquid crystal display (LCD)], designed for displaying graphical information (e.g., values or images measured/acquired by other devices) in colour. The device(s) that generates the visual data is not included with the display unit.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| DQK | Computer, diagnostic, programmable |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| DPZ | Oximeter, ear |
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| OLW | Index-generating electroencephalograph software |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| DXN | System, measurement, blood-pressure, non-invasive |
| BZQ | Monitor, breathing frequency |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| BZK | Spirometer, monitoring (w/wo alarm) |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| DQA | Oximeter |
| FLL | Thermometer, electronic, clinical |
| GWQ | Full-montage Standard Electroencephalograph |
| MUD | Oximeter, tissue saturation |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| DSK | COMPUTER, BLOOD-PRESSURE |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| ORT | Burst suppression detection software for electroencephalograph |
| OMC | Reduced- montage standard electroencephalograph |
| DSJ | Alarm, blood-pressure |
| OLT | Non-normalizing quantitative electroencephalograph software |
| KRB | PROBE, THERMODILUTION |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| QEM | Cerebral oximeter |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K223531 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between -20 and 60 Degrees Celsius |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
4f2fabfa-89e1-46be-9dca-a307789e2d44
May 03, 2024
2
April 19, 2023
May 03, 2024
2
April 19, 2023
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