IRMA™ Airway Adapter

IRMA™ Airway Adapter
IRMA™ Airway Adapter - 106220

Device Description

A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

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

Code: BZA

Device Name: Connector, Airway (Extension)

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 868.5810

Third Party Flag: N

Medical Specialty: AN

Device Identifiers

Device Id: 17350046131597

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

Device Id: 07350046131590

Device Type: Unit of Use

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