DEVICE: CARESCAPE Canvas 1000 (00195278522320)
Device Identifier (DI) Information
CARESCAPE Canvas 1000
5876727
In Commercial Distribution
5876727
GE Healthcare Finland Oy
5876727
In Commercial Distribution
5876727
GE Healthcare Finland Oy
CARESCAPE CANVAS 1000
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? |
|---|---|---|---|---|
| 33586 | General-purpose multi-parameter bedside monitor |
An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| KRB | PROBE, THERMODILUTION |
| BZK | Spirometer, monitoring (w/wo alarm) |
| ORT | Burst suppression detection software for electroencephalograph |
| MUD | Oximeter, tissue saturation |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| BZQ | Monitor, breathing frequency |
| OMC | Reduced- montage standard electroencephalograph |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| OLW | Index-generating electroencephalograph software |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| DPZ | Oximeter, ear |
| GWQ | Full-montage Standard Electroencephalograph |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
| DSK | COMPUTER, BLOOD-PRESSURE |
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| DQA | Oximeter |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| FLL | Thermometer, electronic, clinical |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| DPS | Electrocardiograph |
| OLT | Non-normalizing quantitative electroencephalograph software |
| QEM | Cerebral oximeter |
| DSJ | Alarm, blood-pressure |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| DQK | Computer, diagnostic, programmable |
| DXN | System, measurement, blood-pressure, non-invasive |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K223531 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between -20 and 60 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
57401fa0-da1e-4c29-9204-2ac7aaddc965
April 27, 2023
1
April 19, 2023
April 27, 2023
1
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