BreathCO

Basic Information

• Brand Name: BreathCO
• Primary DI: 15099169297507
• Version / Model: 2900
• Company Name: VITALOGRAPH (IRELAND) LIMITED
• Labeler DUNS: 219683489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-11
• Public Version: 1
• Public Version Date: 2021-03-19
• Public Version Status: New
• Public Device Record Key: dde4e173-9ed2-4421-a383-ff32c4900a7b

Device Description

BREATHCO MONITOR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCJ	Analyzer, gas, carbon-monoxide, gaseous-phase	Anesthesiology	868.1430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35467	Carbon monoxide breath analyser	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05099169297500	GS1		1	In Commercial Distribution
Primary	15099169297507	GS1

Premarket Submissions

Submission Number	Supplement Number
K892524	000