Pediatric Procedural Oxygen Mask with High and Medium Concentration and CO2 Monitoring (Male to Male)

Pediatric Procedural Oxygen Mask with High and Medium Concentration and CO2 Monitoring (Male to Male)
Pedi-POM Elite MM - 1001-MM-PED

A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver oxygen (O2) to a patient's airway, and to sample exhaled respiratory gases for monitoring the patient’s ventilatory status. It includes exhaled air sampling tubing for connection to a carbon dioxide monitor (capnograph), or physiology-monitoring sedation/anaesthesia system, for the measurement of end-tidal carbon dioxide (EtCO2) in expiratory gases; it is typically used during anaesthesia/sedation or bedside monitoring. This is a single-use device.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 20851438008052

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10851438008055

Package Quantity: 30

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: pack

Device Id: 10851438008055

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