DEVICE: CARESCAPE (00840682109826)
Device Identifier (DI) Information
CARESCAPE
Central Station v1
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Central Station v1
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
ASSY CSCS V1 MP100D DESKTOP
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| 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? |
|---|---|---|---|---|
| 38470 | Centralized patient monitor |
A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| DXJ | DISPLAY, CATHODE-RAY TUBE, MEDICAL |
| DOA | RADIOIMMUNOASSAY, DIGOXIN (125-I), GOAT ANTIBODY, ANION EXCHANGE, RESIN SEP. |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| CCI | ANALYZER, GAS, NITROGEN, GASEOUS-PHASE |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| DSB | PLETHYSMOGRAPH, IMPEDANCE |
| BZQ | Monitor, breathing frequency |
| DSK | COMPUTER, BLOOD-PRESSURE |
| GWQ | Full-montage Standard Electroencephalograph |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| BSE | ANALYZER, GAS, HELIUM, GASEOUS-PHASE |
| JEG | ANALYZER, GAS, ARGON, GASEOUS-PHASE |
| DPT | PROBE, BLOOD-FLOW, EXTRAVASCULAR |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Temperature: between -40 and 70 Degrees Celsius |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
2b2165e2-b403-46f1-8fce-b600178bd621
April 22, 2025
5
June 24, 2016
April 22, 2025
5
June 24, 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