DEVICE: CARESCAPE B450 (00840682146135)
Device Identifier (DI) Information
CARESCAPE B450
MBA323
In Commercial Distribution
5805686
GE Healthcare Finland Oy
MBA323
In Commercial Distribution
5805686
GE Healthcare Finland Oy
CARESCAPE B450 MBA323 (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? |
|---|---|---|---|---|
| 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 |
| DQK | Computer, diagnostic, programmable |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| MUD | Oximeter, tissue saturation |
| DPS | Electrocardiograph |
| DXN | System, measurement, blood-pressure, non-invasive |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| DSK | COMPUTER, BLOOD-PRESSURE |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| DQA | Oximeter |
| DPZ | Oximeter, ear |
| KRB | PROBE, THERMODILUTION |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| OLT | Non-normalizing quantitative electroencephalograph software |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
| QEM | Cerebral oximeter |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| OLW | Index-generating electroencephalograph software |
| BZQ | Monitor, breathing frequency |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| FLL | Thermometer, electronic, clinical |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| ORT | Burst suppression detection software for electroencephalograph |
| OMC | Reduced- montage standard electroencephalograph |
| DSJ | Alarm, blood-pressure |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| BZK | Spirometer, monitoring (w/wo alarm) |
| GWQ | Full-montage Standard Electroencephalograph |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K213363 | 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 10 and 40 Degrees Celsius |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
c8d64b0a-ef18-4940-8526-81554ed0871e
May 23, 2022
1
May 13, 2022
May 23, 2022
1
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