BREATHCO MONITOR

BREATHCO MONITOR
BreathCO - 2900

An electronic device intended to be used in a clinical setting to measure the concentration of carbon monoxide (CO) in a gas-mixture sample, exhaled by a patient, using a particular method (e.g., electrochemical, infrared spectroscopy, gas chromatography). It may be used to aid in determining the patient's ventilatory status (typically the lung diffusing capacity), or for determining exhaled CO levels (e.g., during jaundice screening in newborns, or in smoking cessation programs); it may also have the capacity to measure the concentration of CO in the atmosphere.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CCJ

Device Name: Analyzer, Gas, Carbon-Monoxide, 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: 868.1430

Third Party Flag: Y

Medical Specialty: AN

Device Id: 05099169297500

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15099169297507

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A

Device Id: 15099169297507

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