DEVICE: CARESCAPE (00840682103930)
Device Identifier (DI) Information
CARESCAPE
19 inch Display D19KT
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
19 inch Display D19KT
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
CARESCAPE 19 INCH DISPLAY D19KT
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 |
|---|---|
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
| OLT | Non-normalizing quantitative electroencephalograph software |
| ORT | Burst suppression detection software for electroencephalograph |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| OMC | Reduced- montage standard electroencephalograph |
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| FLL | Thermometer, electronic, clinical |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| DSJ | ALARM, BLOOD-PRESSURE |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| DPZ | Oximeter, ear |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| OLW | Index-generating electroencephalograph software |
| KRB | PROBE, THERMODILUTION |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| DQA | Oximeter |
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| DPS | ELECTROCARDIOGRAPH |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| BZQ | Monitor, breathing frequency |
| GWQ | Full-montage Standard Electroencephalograph |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| DSK | COMPUTER, BLOOD-PRESSURE |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| BZK | Spirometer, monitoring (w/wo alarm) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K131414 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 0 and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
97acf5c7-2b86-4520-b390-c1384208a9ad
May 09, 2025
7
June 03, 2016
May 09, 2025
7
June 03, 2016
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
[?]
+1(800)558-5120
xx@xx.xx
xx@xx.xx