DEVICE: NA (00840682104173)
Device Identifier (DI) Information
NA
E-sCO-00
In Commercial Distribution
E-sCO-00
GE Healthcare Finland Oy
E-sCO-00
In Commercial Distribution
E-sCO-00
GE Healthcare Finland Oy
E-SCO-00, MODULE ASSEMBLY
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? |
|---|---|---|---|---|
| 37061 | Patient monitoring system module, multiple-gas |
A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| BZK | Spirometer, monitoring (w/wo alarm) |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| BZL | COMPUTER, OXYGEN-UPTAKE |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
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 Atmospheric Pressure: between 50 and 106 KiloPascal |
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure: between 66 and 106 KiloPascal |
| Handling Environment Humidity: between 10 and 98 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 40 Degrees Celsius |
| Storage Environment Temperature: between -25 and 60 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
65d804d5-7e27-4609-9849-ecbb02e8976f
March 20, 2025
8
June 03, 2016
March 20, 2025
8
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