IRMA™ AX+

IRMA™ AX+
IRMA™ AX+ - 4768

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: 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: 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: 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: 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: 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

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: 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

Device Identifiers

Device Id: 07350046131736

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