ISA™ OR+ - OR+ ROOT
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: CCL
Device Name: Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1720
Third Party Flag: Y
Medical Specialty: AN
Code: NHQ
Device Name: Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: NHP
Device Name: Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: NHO
Device Name: Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: CBS
Device Name: Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1620
Third Party Flag: Y
Medical Specialty: AN
Code: CBR
Device Name: Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1700
Third Party Flag: Y
Medical Specialty: AN
Code: CBQ
Device Name: Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: CCK
Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 868.1400
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 07350046131828
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A