DEVICE: CARESCAPE RAD (00840682123433)
Device Identifier (DI) Information
CARESCAPE RAD
MBRA001
In Commercial Distribution
CARESCAPE-RAD
GE Healthcare Finland Oy
MBRA001
In Commercial Distribution
CARESCAPE-RAD
GE Healthcare Finland Oy
CARESCAPE RAD
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? |
|---|---|---|---|---|
| 62911 | Physiologic monitoring system alarm |
An electronic device intended to be connected to a physiologic monitoring system to provide an audible and/or visual indicator, in the event of out-of-range parameter detection, to notify medical staff that (urgent) assistance is needed by the patient. It is used by medical professionals and caregivers in the healthcare facility.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| ORT | Burst suppression detection software for electroencephalograph |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| BZQ | Monitor, breathing frequency |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| DQK | Computer, diagnostic, programmable |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| DPZ | Oximeter, ear |
| BZK | Spirometer, monitoring (w/wo alarm) |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| OMC | Reduced- montage standard electroencephalograph |
| DQA | Oximeter |
| DSK | COMPUTER, BLOOD-PRESSURE |
| FLL | Thermometer, electronic, clinical |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| DPS | Electrocardiograph |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| DSJ | Alarm, blood-pressure |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| DXN | System, measurement, blood-pressure, non-invasive |
| OLT | Non-normalizing quantitative electroencephalograph software |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| KRB | PROBE, THERMODILUTION |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| OLW | Index-generating electroencephalograph software |
| GWQ | Full-montage Standard Electroencephalograph |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K213363 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Handling Environment Temperature: between 10 and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
a0f88ef4-bc0a-4e80-b9aa-811d1e47078c
October 11, 2024
2
March 05, 2020
October 11, 2024
2
March 05, 2020
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(999)999-9999
xx@xx.xx
xx@xx.xx