- Physicians Office Resource

IRMA CO2, D8 Connector
IRMA - 4495

Device Description

A mains electricity (AC-powered) bedside device designed to measure and display a non-ambulatory patient's respiratory functions. Measurements include concentration of respiratory gas components [e.g., carbon dioxide (CO2), oxygen (O2)] and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea). The device may also measure airway pressure (Paw) and oesophageal pressure (Pes). It is typically equipped with audible and/or visual alarms that are triggered when respiratory parameters drop below or exceed pre-set limits.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Handling Environment Temperature - Degrees Celsius

70.00
-40.00

Storage Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Storage Environment Temperature - Degrees Celsius

70.00
-40.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 07350046132306

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

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