B1X5 Software Upgrade

Basic Information

• Brand Name: B1X5 Software Upgrade
• Primary DI: 00840682141291
• Version / Model: V1.5
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Labeler DUNS: 784985108
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-18
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: dd097498-4601-49da-a4c0-3adcd26e51e9

Device Description

B125/B105 V1.5 SW PACK (USB) - MD

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OLW	Index-generating electroencephalograph software	Neurology	882.1400	2
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2
DPZ	Oximeter, ear	Cardiovascular	870.2710	2
CBQ	ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)	Anesthesiology	868.1500	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
DQA	Oximeter	Cardiovascular	870.2700	2
MLD	MONITOR, ST SEGMENT WITH ALARM	Cardiovascular	870.1025	2
DXN	System, measurement, blood-pressure, non-invasive	Cardiovascular	870.1130	2
OMC	Reduced- montage standard electroencephalograph	Neurology	882.1400	2
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1700	2
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2
CBS	ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1620	2
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2
DSJ	Alarm, blood-pressure	Cardiovascular	870.1100	2
DQK	Computer, diagnostic, programmable	Cardiovascular	870.1425	2
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2
ORT	Burst suppression detection software for electroencephalograph	Neurology	882.1400	2
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2
KRB	PROBE, THERMODILUTION	Cardiovascular	870.1915	2
NHO	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682141291	GS1

Premarket Submissions

Submission Number	Supplement Number
K201941	000