NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682104074
• Version / Model: N-CAiO-00
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 17aa91a9-c716-4a3d-b723-073c47720aae

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
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
CBS	ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1620	2
NHO	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1700	2
CBQ	ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)	Anesthesiology	868.1500	2
DSB	PLETHYSMOGRAPH, IMPEDANCE	Cardiovascular	870.2770	2
BZQ	Monitor, breathing frequency	Anesthesiology	868.2375	2
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2
DQA	Oximeter	Cardiovascular	870.2700	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2
DRT	MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM)	Cardiovascular	870.2300	2
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682104074	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133576	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 98 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 66 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity