DEVICE: CARESCAPE (00840682108379)
Device Identifier (DI) Information
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
DQA | Oximeter |
DPZ | Oximeter, ear |
DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
DPS | ELECTROCARDIOGRAPH |
GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
BZQ | Monitor, breathing frequency |
DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
DSJ | ALARM, BLOOD-PRESSURE |
MLD | MONITOR, ST SEGMENT WITH ALARM |
BZK | Spirometer, monitoring (w/wo alarm) |
DSI | DETECTOR AND ALARM, ARRHYTHMIA |
DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
GWQ | Full-montage Standard Electroencephalograph |
FLL | Thermometer, electronic, clinical |
OLW | Index-generating electroencephalograph software |
CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
BZL | COMPUTER, OXYGEN-UPTAKE |
OMC | Reduced- montage standard electroencephalograph |
KRB | PROBE, THERMODILUTION |
OLT | Non-normalizing quantitative electroencephalograph software |
ORT | Burst suppression detection software for electroencephalograph |
MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
DSK | COMPUTER, BLOOD-PRESSURE |
DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K131223 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a4e00cf7-47a7-4c41-8614-1a70212c8069
November 10, 2021
6
July 22, 2016
November 10, 2021
6
July 22, 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