DEVICE: B1X5 Software Upgrade (00840682141291)
Device Identifier (DI) Information
B1X5 Software Upgrade
V1.5
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V1.5
Not in Commercial Distribution
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
B125/B105 V1.5 SW PACK (USB) - MD
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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| OLW | Index-generating electroencephalograph software |
| NHQ | Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration) |
| OLT | Non-normalizing quantitative electroencephalograph software |
| DPZ | Oximeter, ear |
| CBQ | ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION) |
| CCL | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| DQA | Oximeter |
| MLD | MONITOR, ST SEGMENT WITH ALARM |
| DXN | System, measurement, blood-pressure, non-invasive |
| OMC | Reduced- montage standard electroencephalograph |
| CBR | ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.) |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) |
| CBS | ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.) |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| DSJ | Alarm, blood-pressure |
| DQK | Computer, diagnostic, programmable |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA |
| BZQ | Monitor, breathing frequency |
| ORT | Burst suppression detection software for electroencephalograph |
| DRT | MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) |
| FLL | Thermometer, electronic, clinical |
| KRB | PROBE, THERMODILUTION |
| NHO | Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration) |
| GWQ | Full-montage Standard Electroencephalograph |
| NHP | Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration) |
| DSK | COMPUTER, BLOOD-PRESSURE |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
dd097498-4601-49da-a4c0-3adcd26e51e9
April 17, 2025
3
November 18, 2020
April 17, 2025
3
November 18, 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
[?]
No Customer Contact currently defined