DEVICE: NA (00840682103978)
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? |
|---|---|---|---|---|
| 36757 | Patient monitoring system module rack |
A device typically designed as a framework or specially constructed holder where module devices used with a patient monitoring system can be plugged in and connected to the parent device usually by one cable. This device is typically used to facilitate connection to the patient from the modules using standard length cables and leads when the parent device is situated away from the patient (out of reach), e.g., the parent device may be mounted to a wall support or a ceiling pendant arm (Utility supply system).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GWQ | Full-montage Standard Electroencephalograph |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| OLW | Index-generating electroencephalograph software |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| ORT | Burst suppression detection software for electroencephalograph |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| DSK | COMPUTER, BLOOD-PRESSURE |
| GWJ | STIMULATOR, AUDITORY, EVOKED RESPONSE |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| DSJ | ALARM, BLOOD-PRESSURE |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| OMC | Reduced- montage standard electroencephalograph |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| BZK | Spirometer, monitoring (w/wo alarm) |
| DPZ | Oximeter, ear |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| DXN | SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| DPS | ELECTROCARDIOGRAPH |
| OLT | Non-normalizing quantitative electroencephalograph software |
| BZQ | Monitor, breathing frequency |
| KRB | PROBE, THERMODILUTION |
| KOI | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| DQA | Oximeter |
| FLL | Thermometer, electronic, clinical |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K213363 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
| Handling Environment Temperature: between 10 and 35 Degrees Celsius |
| Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
bd7a97fb-2fcf-42b4-ad70-075341bba065
October 11, 2024
4
June 03, 2016
October 11, 2024
4
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