NA

Basic Information

• Brand Name: NA
• Primary DI: 00195278524089
• Version / Model: F2-01
• Catalog Number: 5861293
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-19
• Public Version: 1
• Public Version Date: 2023-04-27
• Public Version Status: New
• Public Device Record Key: c1ef7419-14be-4471-be6e-711dff26977c

Device Description

F2 FRAME BASIC UNIT HLA

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: Yes
• 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
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2
KRB	PROBE, THERMODILUTION	Cardiovascular	870.1915	2
DQA	Oximeter	Cardiovascular	870.2700	2
OLT	Non-normalizing quantitative electroencephalograph software	Neurology	882.1400	2
NHO	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CBQ	ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)	Anesthesiology	868.1500	2
DSJ	Alarm, blood-pressure	Cardiovascular	870.1100	2
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1700	2
DPZ	Oximeter, ear	Cardiovascular	870.2710	2
ORT	Burst suppression detection software for electroencephalograph	Neurology	882.1400	2
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2
MUD	Oximeter, tissue saturation	Cardiovascular	870.2700	2
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2
CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)	Anesthesiology	868.2600	2
QEM	Cerebral oximeter	Cardiovascular	870.2700	2
MLD	MONITOR, ST SEGMENT WITH ALARM	Cardiovascular	870.1025	2
DPS	Electrocardiograph	Cardiovascular	870.2340	2
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
KOI	STIMULATOR, NERVE, PERIPHERAL, ELECTRIC	Anesthesiology	868.2775	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CBS	ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1620	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
OLW	Index-generating electroencephalograph software	Neurology	882.1400	2
BZL	COMPUTER, OXYGEN-UPTAKE	Anesthesiology	868.1730	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE	Neurology	882.1900	2
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION	Cardiovascular	870.1435	2
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2
OMC	Reduced- montage standard electroencephalograph	Neurology	882.1400	2
DQK	Computer, diagnostic, programmable	Cardiovascular	870.1425	2
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2
DXN	System, measurement, blood-pressure, non-invasive	Cardiovascular	870.1130	2
BZK	Spirometer, monitoring (w/wo alarm)	Anesthesiology	868.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00195278524089	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K223531	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius